Activation of energy devices

ABSTRACT

Various systems and methods for controlling the activation of energy surgical instruments are disclosed. An advance energy surgical instrument, such an electrosurgical instrument or an ultrasonic surgical instrument, can include one or more sensor assemblies for detecting the state or position of the end effector, arm, or other components of the surgical instrument. A control circuit can be configured to control the activation of the surgical instrument according to the state or position of the components of the surgical instrument.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,995, titled CONTROLLING ANULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION, filed onAug. 23, 2018, the disclosure of which is herein incorporated byreference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,998, titled SITUATIONALAWARENESS OF ELECTROSURGICAL SYSTEMS, filed on Aug. 23, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,999, titled INTERRUPTION OFENERGY DUE TO INADVERTENT CAPACITIVE COUPLING, filed on Aug. 23, 2018,the disclosure of which is herein incorporated by reference in itsentirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,994, titled BIPOLARCOMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGYMODALITY, filed on Aug. 23, 2018, the disclosure of which is hereinincorporated by reference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,996, titled RADIO FREQUENCYENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS, filed on Aug.23, 2018, the disclosure of which is herein incorporated by reference inits entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/692,747, titled SMARTACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on Jun. 30,2018, to U.S. Provisional Patent Application No. 62/692,748, titledSMART ENERGY ARCHITECTURE, filed on Jun. 30, 2018, and to U.S.Provisional Patent Application No. 62/692,768, titled SMART ENERGYDEVICES, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/640,417,titled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR, filed Mar. 8, 2018, and to U.S. Provisional Patent ApplicationSer. No. 62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTORAND CONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, the disclosure of eachof which is herein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/650,898 filed onMar. 30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLEARRAY ELEMENTS, to U.S. Provisional Patent Application Ser. No.62/650,887, titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES,filed Mar. 30, 2018, to U.S. Provisional Patent Application Ser. No.62/650,882, titled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICALPLATFORM, filed Mar. 30, 2018, and to U.S. Provisional PatentApplication Ser. No. 62/650,877, titled SURGICAL SMOKE EVACUATIONSENSING AND CONTROLS, filed Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S.Provisional Patent Application Ser. No. 62/611,340, titled CLOUD-BASEDMEDICAL ANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

In a surgical environment, smart energy devices may be needed in a smartenergy architecture environment.

SUMMARY

In one general aspect, a surgical instrument comprising: an ultrasonicblade, an arm pivotable relative to the ultrasonic blade between an openposition and a closed position, a transducer assembly coupled to theultrasonic blade, a sensor configured to sense a position of the armbetween the open position and the closed position, and a control circuitcoupled to the transducer assembly and the sensor. The transducerassembly comprises at least two piezoelectric elements configured toultrasonically oscillate the ultrasonic blade. The control circuit isconfigured to activate the transducer assembly according to a positionof the arm detected by the sensor relative to a threshold position.

In another general aspect, a surgical instrument comprising: anultrasonic blade, an arm pivotable relative to the ultrasonic bladebetween an open position and a closed position, a transducer assemblycoupled to the ultrasonic blade, a first sensor configured to sense afirst force as the arm transitions to the closed position, a secondsensor configured to sense a second force as the arm transitions to theopen position, and a control circuit coupled to the transducer assembly,the first sensor, and the second sensor. The transducer assemblycomprises at least two piezoelectric elements configured toultrasonically oscillate the ultrasonic blade. The control circuit isconfigured to activate the transducer assembly according to the firstforce sensed by the first sensor relative to a first threshold and thesecond force sensed by the second sensor relative to a second threshold.

In yet another general aspect, a surgical instrument comprising: anultrasonic blade, a transducer assembly coupled to the ultrasonic blade,a sensor configured to sense a force thereagainst, and a control circuitcoupled to the transducer assembly and the sensor. The transducerassembly comprises at least two piezoelectric elements configured toultrasonically oscillate the ultrasonic blade. The control circuit isconfigured to activate the transducer assembly according to the forcesensed by the sensor relative to a threshold force.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 16 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 18 is a system configured to execute adaptive ultrasonic bladecontrol algorithms in a surgical data network comprising a modularcommunication hub, in accordance with at least one aspect of the presentdisclosure.

FIG. 19 illustrates an example of a generator, in accordance with atleast one aspect of the present disclosure.

FIG. 20 is a surgical system comprising a generator and various surgicalinstruments usable therewith, in accordance with at least one aspect ofthe present disclosure.

FIG. 21 is an end effector, in accordance with at least one aspect ofthe present disclosure.

FIG. 22 is a diagram of the surgical system of FIG. 20, in accordancewith at least one aspect of the present disclosure.

FIG. 23 is a model illustrating motional branch current, in accordancewith at least one aspect of the present disclosure.

FIG. 24 is a structural view of a generator architecture, in accordancewith at least one aspect of the present disclosure.

FIGS. 25A-25C are functional views of a generator architecture, inaccordance with at least one aspect of the present disclosure.

FIGS. 26A-26B are structural and functional aspects of a generator, inaccordance with at least one aspect of the present disclosure.

FIG. 27 is a schematic diagram of one aspect of an ultrasonic drivecircuit.

FIG. 28 is a schematic diagram of a control circuit, in accordance withat least one aspect of the present disclosure.

FIG. 29 shows a simplified block circuit diagram illustrating anotherelectrical circuit contained within a modular ultrasonic surgicalinstrument, in accordance with at least one aspect of the presentdisclosure.

FIG. 30 illustrates a generator circuit partitioned into multiplestages, in accordance with at least one aspect of the presentdisclosure.

FIG. 31 illustrates a generator circuit partitioned into multiple stageswhere a first stage circuit is common to the second stage circuit, inaccordance with at least one aspect of the present disclosure.

FIG. 32 is a schematic diagram of one aspect of a drive circuitconfigured for driving a high-frequency current (RF), in accordance withat least one aspect of the present disclosure.

FIG. 33 illustrates a control circuit that allows a dual generatorsystem to switch between the RF generator and the ultrasonic generatorenergy modalities for a surgical instrument.

FIG. 34 illustrates a diagram of one aspect of a surgical instrumentcomprising a feedback system for use with a surgical instrument,according to one aspect of the resent disclosure.

FIG. 35 illustrates one aspect of a fundamental architecture for adigital synthesis circuit such as a direct digital synthesis (DDS)circuit configured to generate a plurality of wave shapes for theelectrical signal waveform for use in a surgical instrument, inaccordance with at least one aspect of the present disclosure.

FIG. 36 illustrates one aspect of direct digital synthesis (DDS) circuitconfigured to generate a plurality of wave shapes for the electricalsignal waveform for use in surgical instrument, in accordance with atleast one aspect of the present disclosure.

FIG. 37 illustrates one cycle of a discrete time digital electricalsignal waveform, in accordance with at least one aspect of the presentdisclosure of an analog waveform (shown superimposed over a discretetime digital electrical signal waveform for comparison purposes), inaccordance with at least one aspect of the present disclosure.

FIG. 38 illustrates an ultrasonic surgical instrument system, inaccordance with at least one aspect of the present disclosure.

FIGS. 39A-39C illustrate a piezoelectric transducer, in accordance withat least one aspect of the present disclosure.

FIG. 40 illustrates a D31 ultrasonic transducer architecture thatincludes an ultrasonic waveguide and one or more piezoelectric elementsfixed to the ultrasonic waveguide, in accordance with at least oneaspect of the present disclosure.

FIG. 41 illustrates a cutaway view of an ultrasonic surgical instrument,in accordance with at least one aspect of the present disclosure.

FIG. 42 illustrates an exploded view of the ultrasonic surgicalinstrument in FIG. 41, in accordance with at least one aspect of thepresent disclosure.

FIG. 43 illustrates a block diagram of a surgical system, in accordancewith at least one aspect of the present disclosure.

FIG. 44 illustrates a perspective view of a surgical instrumentincluding a sensor assembly configured to detect a user-worn magneticreference, in accordance with at least one aspect of the presentdisclosure.

FIG. 45A illustrates a sectional view along line 44-44 of a surgicalinstrument including a sensor assembly configured to detect an integralmagnetic reference, in accordance with at least one aspect of thepresent disclosure.

FIG. 45B illustrates a detail view of the surgical instrument of FIG.45A in a first position, in accordance with at least one aspect of thepresent disclosure.

FIG. 45C illustrates a detail view of the surgical instrument of FIG.45A in a second position, in accordance with at least one aspect of thepresent disclosure.

FIG. 46A illustrates a perspective view of a surgical instrumentincluding a sensor assembly configured to detect contact thereagainstthat is oriented orthogonally, in accordance with at least one aspect ofthe present disclosure.

FIG. 46B illustrates a perspective view of a surgical instrumentincluding a sensor assembly configured to detect contact thereagainstthat is oriented laterally, in accordance with at least one aspect ofthe present disclosure.

FIG. 47 illustrates a circuit diagram of the surgical instrument ofeither FIG. 46A or FIG. 46B, in accordance with at least one aspect ofthe present disclosure.

FIG. 48A illustrates a perspective view of a surgical instrumentincluding a sensor assembly configured to detect closure of the surgicalinstrument, wherein the surgical instrument is in an open position, inaccordance with at least one aspect of the present disclosure.

FIG. 48B illustrates a perspective view of a surgical instrumentincluding a sensor assembly configured to detect closure of the surgicalinstrument, wherein the surgical instrument is in a first closedposition, in accordance with at least one aspect of the presentdisclosure.

FIG. 48C illustrates a perspective view of a surgical instrumentincluding a sensor assembly configured to detect closure of the surgicalinstrument, wherein the surgical instrument is in a second closedposition, in accordance with at least one aspect of the presentdisclosure.

FIG. 49A illustrates a perspective view of a surgical instrumentincluding a sensor assembly configured to detect opening of the surgicalinstrument, in accordance with at least one aspect of the presentdisclosure.

FIG. 49B illustrates a sectional view along line 48B-48B of the surgicalinstrument of FIG. 49A, in accordance with at least one aspect of thepresent disclosure.

FIG. 49C illustrates an exploded perspective view of the surgicalinstrument of FIG. 49A, in accordance with at least one aspect of thepresent disclosure.

FIG. 49D illustrates a perspective view of the surgical instrument ofFIG. 49A, in accordance with at least one aspect of the presentdisclosure.

FIG. 49E illustrates a detail view of a portion of FIG. 49D, inaccordance with at least one aspect of the present disclosure.

FIG. 49F illustrates a perspective view of the interior face of the armof the surgical instrument of FIG. 49A, in accordance with at least oneaspect of the present disclosure.

FIG. 50 illustrates a perspective view of a surgical instrumentincluding a sensor assembly comprising a pair of sensors for controllingthe activation of the surgical instrument, in accordance with at leastone aspect of the present disclosure.

FIG. 51 illustrates a perspective view of a surgical instrumentcomprising a deactivation switch, in accordance with at least one aspectof the present disclosure.

FIG. 52 illustrates a perspective view of a retractor comprising asensor, in accordance with at least one aspect of the presentdisclosure.

FIG. 53 illustrates a perspective view of a retractor comprising adisplay in use at a surgical site, in accordance with at least oneaspect of the present disclosure.

FIG. 54 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 28, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Docket No. END8536USNP2/180107-2, titled        ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM        THEREFOR;    -   U.S. patent application Docket No. END8560USNP2/180106-2, titled        TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL        SYSTEM THEREFOR;    -   U.S. patent application Docket No. END8561USNP1/180144-1, titled        RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS;    -   U.S. patent application Docket No. END8563USNP1/180139-1, titled        CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO        TISSUE LOCATION;    -   U.S. patent application Docket No. END8563USNP2/180139-2, titled        CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT        ACCORDING TO THE PRESENCE OF TISSUE;    -   U.S. patent application Docket No. END8563USNP3/180139-3, titled        DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM;    -   U.S. patent application Docket No. END8563USNP4/180139-4, titled        DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM        ACCORDING TO FREQUENCY SHIFT;    -   U.S. patent application Docket No. END8563USNP5/180139-5, titled        DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR;    -   U.S. patent application Docket No. END8564USNP1/180140-1, titled        SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. patent application Docket No. END8564USNP2/180140-2, titled        MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS        OF AN ELECTROSURGICAL INSTRUMENT;    -   U.S. patent application Docket No. END8564USNP3/180140-3, titled        DETECTION OF END EFFECTOR IMMERSION IN LIQUID;    -   U.S. patent application Docket No. END8565USNP1/180142-1, titled        INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. patent application Docket No. END8565USNP2/180142-2, titled        INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP;        and    -   U.S. patent application Docket No. END8566USNP1/180143-1, titled        BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE        BASED ON ENERGY MODALITY.

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 23, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/721,995, titled        CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO        TISSUE LOCATION;    -   U.S. Provisional Patent Application No. 62/721,998, titled        SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. Provisional Patent Application No. 62/721,999, titled        INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. Provisional Patent Application No. 62/721,994, titled        BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE        BASED ON ENERGY MODALITY; and    -   U.S. Provisional Patent Application No. 62/721,996, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/692,747, titled SMART        ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;    -   U.S. Provisional Patent Application No. 62/692,748, titled SMART        ENERGY ARCHITECTURE; and    -   U.S. Provisional Patent Application No. 62/692,768, titled SMART        ENERGY DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/024,090, titled CAPACITIVE        COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;    -   U.S. patent application Ser. No. 16/024,057, titled CONTROLLING        A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;    -   U.S. patent application Ser. No. 16/024,067, titled SYSTEMS FOR        ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE        INFORMATION;    -   U.S. patent application Ser. No. 16/024,075, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,083, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,094, titled SURGICAL        SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION        IRREGULARITIES;    -   U.S. patent application Ser. No. 16/024,138, titled SYSTEMS FOR        DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS        TISSUE;    -   U.S. patent application Ser. No. 16/024,150, titled SURGICAL        INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;    -   U.S. patent application Ser. No. 16/024,160, titled VARIABLE        OUTPUT CARTRIDGE SENSOR ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,124, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. patent application Ser. No. 16/024,132, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE CIRCUIT;    -   U.S. patent application Ser. No. 16/024,141, titled SURGICAL        INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,162, titled SURGICAL        SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;    -   U.S. patent application Ser. No. 16/024,066, titled SURGICAL        EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. patent application Ser. No. 16/024,096, titled SURGICAL        EVACUATION SENSOR ARRANGEMENTS;    -   U.S. patent application Ser. No. 16/024,116, titled SURGICAL        EVACUATION FLOW PATHS;    -   U.S. patent application Ser. No. 16/024,149, titled SURGICAL        EVACUATION SENSING AND GENERATOR CONTROL;    -   U.S. patent application Ser. No. 16/024,180, titled SURGICAL        EVACUATION SENSING AND DISPLAY;    -   U.S. patent application Ser. No. 16/024,245, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. patent application Ser. No. 16/024,258, titled SMOKE        EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR        INTERACTIVE SURGICAL PLATFORM;    -   U.S. patent application Ser. No. 16/024,265, titled SURGICAL        EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION        BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and    -   U.S. patent application Ser. No. 16/024,273, titled DUAL        IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/691,228, titled        A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS        WITH ELECTROSURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/691,227, titled        CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE        PARAMETERS;    -   U.S. Provisional Patent Application Ser. No. 62/691,230, titled        SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. Provisional Patent Application Ser. No. 62/691,219, titled        SURGICAL EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. Provisional Patent Application Ser. No. 62/691,257, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/691,262, titled        SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR        COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE;        and    -   U.S. Provisional Patent Application Ser. No. 62/691,251, titled        DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. Provisionalpatent application, filed on Apr. 19, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/659,900, titled        METHOD OF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/650,898 filed on Mar.        30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH        SEPARABLE ARRAY ELEMENTS;    -   U.S. Provisional Patent Application Ser. No. 62/650,887, titled        SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/650,882, titled        SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and    -   U.S. Provisional Patent Application Ser. No. 62/650,877, titled        SURGICAL SMOKE EVACUATION SENSING AND CONTROLS

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING.    -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES.    -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/640,417, titled        TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM        THEREFOR; and    -   U.S. Provisional Patent Application Ser. No. 62/640,415, titled        ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM        THEREFOR.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional patent application Serial No. U.S. Provisional        Patent Application Ser. No. 62/611,341, titled INTERACTIVE        SURGICAL PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/611,340, titled        CLOUD-BASED MEDICAL ANALYTICS; and    -   U.S. Provisional Patent Application Ser. No. 62/611,339, titled        ROBOT ASSISTED SURGICAL PLATFORM.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Various aspects are directed to improved ultrasonic surgical devices,electrosurgical devices and generators for use therewith. Aspects of theultrasonic surgical devices can be configured for transecting and/orcoagulating tissue during surgical procedures, for example. Aspects ofthe electrosurgical devices can be configured for transecting,coagulating, scaling, welding and/or desiccating tissue during surgicalprocedures, for example.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3, the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts,

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, each of which is herein incorporated byreference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to W-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, in accordance with at least one aspect of thepresent disclosure. In the illustrated aspect, the USB network hubdevice 300 employs a TUSB2036 integrated circuit hub by TexasInstruments. The USB network hub 300 is a CMOS device that provides anupstream USB transceiver port 302 and up to three downstream USBtransceiver ports 304, 306, 308 in compliance with the USB 2.0specification. The upstream USB transceiver port 302 is a differentialroot data port comprising a differential data minus (DM0) input pairedwith a differential data plus (DP0) input. The three downstream USBtransceiver ports 304, 306, 308 are differential data ports where eachport includes differential data plus (DP1-DP3) outputs paired withdifferential data minus (DM1-DM3) outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive a clamp arm closure member. A trackingsystem 480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of the closure member. Additional motors may be provided at thetool driver interface to control closure tube travel, shaft rotation,articulation, or clamp arm closure, or a combination of the above. Adisplay 473 displays a variety of operating conditions of theinstruments and may include touch screen functionality for data input.Information displayed on the display 473 may be overlaid with imagesacquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife,articulation systems, clamp arm, or a combination of the above. In oneaspect, the microcontroller 461 includes a processor 462 and a memory468. The electric motor 482 may be a brushed direct current (DC) motorwith a gearbox and mechanical links to an articulation or knife system.In one aspect, a motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. Other motor drivers may be readily substituted foruse in the tracking system 480 comprising an absolute positioningsystem. A detailed description of an absolute positioning system isdescribed in U.S. Patent Application Publication No. 2017/0296213,titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING ANDCUTTING INSTRUMENT, which published on Oct. 19, 2017, which is hereinincorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable battery cells. In at least one example,the battery cells can be lithium-ion batteries which can be couplable toand separable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the low-side FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem provides a unique position signal corresponding to the locationof a displacement member. In one aspect, the displacement memberrepresents a longitudinally movable drive member comprising a rack ofdrive teeth for meshing engagement with a corresponding drive gear of agear reducer assembly. In other aspects, the displacement memberrepresents the firing member, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember represents a longitudinal displacement member to open and close aclamp arm, which can be adapted and configured to include a rack ofdrive teeth. In other aspects, the displacement member represents aclamp arm closure member configured to close and to open a clamp arm ofa stapler, ultrasonic, or electrosurgical device, or combinations of theabove. Accordingly, as used herein, the term displacement member is usedgenerically to refer to any movable member of the surgical instrument ortool such as the drive member, the clamp arm, or any element that can bedisplaced. Accordingly, the absolute positioning system can, in effect,track the displacement of the clamp arm by tracking the lineardisplacement of the longitudinally movable drive member.

In other aspects, the absolute positioning system can be configured totrack the position of a clamp arm in the process of closing or opening.In various other aspects, the displacement member may be coupled to anyposition sensor 472 suitable for measuring linear displacement. Thus,the longitudinally movable drive member, or clamp arm, or combinationsthereof, may be coupled to any suitable linear displacement sensor.Linear displacement sensors may include contact or non-contactdisplacement sensors. Linear displacement sensors may comprise linearvariable differential transformers (LVDT), differential variablereluctance transducers (DVRT), a slide potentiometer, a magnetic sensingsystem comprising a movable magnet and a series of linearly arrangedHall effect sensors, a magnetic sensing system comprising a fixed magnetand a series of movable, linearly arranged Hall effect sensors, anoptical sensing system comprising a movable light source and a series oflinearly arranged photo diodes or photo detectors, an optical sensingsystem comprising a fixed light source and a series of movable linearly,arranged photo diodes or photo detectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member to open and close a clamp arm.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d₁ of theof the displacement member, where d₁ is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d₁+d₂+d₀ ofthe displacement member. The output of the position sensor 472 isprovided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertia, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil in a stapler or a clamp arm in an ultrasonic orelectrosurgical instrument. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to a closure member coupledto a clamp arm of the surgical instrument or tool or the force appliedby a clamp arm to tissue located in the jaws of an ultrasonic orelectrosurgical instrument. Alternatively, a current sensor 478 can beemployed to measure the current drawn by the motor 482. The displacementmember also may be configured to engage a clamp arm to open or close theclamp arm. The force sensor may be configured to measure the clampingforce on tissue. The force required to advance the displacement membercan correspond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A load sensor 476 can measure the force used to operate theclamp arm element, for example, to capture tissue between the clamp armand an ultrasonic blade or to capture tissue between the clamp arm and ajaw of an electrosurgical instrument. A magnetic field sensor can beemployed to measure the thickness of the captured tissue. Themeasurement of the magnetic field sensor also may be converted to adigital signal and provided to the processor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool according to oneaspect of this disclosure. The combinational logic circuit 510 can beconfigured to implement various processes described herein. Thecombinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 13) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 14) and the sequential logic circuit 520.

FIG. 16 illustrates a schematic diagram of a surgical instrument 750configured to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the closure member 764. The surgicalinstrument 750 comprises an end effector 752 that may comprise a clamparm 766, a closure member 764, and an ultrasonic blade 768 coupled to anultrasonic transducer 769 driven by an ultrasonic generator 771.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the closure member 764, can be measured byan absolute positioning system, sensor arrangement, and position sensor784. Because the closure member 764 is coupled to a longitudinallymovable drive member, the position of the closure member 764 can bedetermined by measuring the position of the longitudinally movable drivemember employing the position sensor 784. Accordingly, in the followingdescription, the position, displacement, and/or translation of theclosure member 764 can be achieved by the position sensor 784 asdescribed herein. A control circuit 760 may be programmed to control thetranslation of the displacement member, such as the closure member 764.The control circuit 760, in some examples, may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to controlthe displacement member, e.g., the closure member 764, in the mannerdescribed. In one aspect, a timer/counter 781 provides an output signal,such as the elapsed time or a digital count, to the control circuit 760to correlate the position of the closure member 764 as determined by theposition sensor 784 with the output of the timer/counter 781 such thatthe control circuit 760 can determine the position of the closure member764 at a specific time (t) relative to a starting position. Thetimer/counter 781 may be configured to measure elapsed time, countexternal events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theclosure member 764 via a transmission 756. The transmission 756 mayinclude one or more gears or other linkage components to couple themotor 754 to the closure member 764. A position sensor 784 may sense aposition of the closure member 764. The position sensor 784 may be orinclude any type of sensor that is capable of generating position datathat indicate a position of the closure member 764. In some examples,the position sensor 784 may include an encoder configured to provide aseries of pulses to the control circuit 760 as the closure member 764translates distally and proximally. The control circuit 760 may trackthe pulses to determine the position of the closure member 764. Othersuitable position sensors may be used, including, for example, aproximity sensor. Other types of position sensors may provide othersignals indicating motion of the closure member 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theclosure member 764 by aggregating the number and direction of steps thatthe motor 754 has been instructed to execute. The position sensor 784may be located in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe clamp arm 766 during a clamped condition. The strain gauge providesan electrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe clamp arm 766 and the ultrasonic blade 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theclamp arm 766 and the ultrasonic blade 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theclamp arm 766 by a closure drive system. For example, one or moresensors 788 can be at an interaction point between a closure tube andthe clamp arm 766 to detect the closure forces applied by a closure tubeto the clamp arm 766. The forces exerted on the clamp arm 766 can berepresentative of the tissue compression experienced by the tissuesection captured between the clamp arm 766 and the ultrasonic blade 768.The one or more sensors 788 can be positioned at various interactionpoints along the closure drive system to detect the closure forcesapplied to the clamp arm 766 by the closure drive system. The one ormore sensors 788 may be sampled in real time during a clamping operationby a processor of the control circuit 760. The control circuit 760receives real-time sample measurements to provide and analyze time-basedinformation and assess, in real time, closure forces applied to theclamp arm 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the closure member 764corresponds to the current drawn by the motor 754. The force isconverted to a digital signal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move a closure member 764 in theend effector 752 at or near a target velocity. The surgical instrument750 can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or closure member 764, bya brushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical sealing andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable clamp arm766 and, when configured for use, an ultrasonic blade 768 positionedopposite the clamp arm 766. A clinician may grasp tissue between theclamp arm 766 and the ultrasonic blade 768, as described herein. Whenready to use the instrument 750, the clinician may provide a firingsignal, for example by depressing a trigger of the instrument 750. Inresponse to the firing signal, the motor 754 may drive the displacementmember distally along the longitudinal axis of the end effector 752 froma proximal stroke begin position to a stroke end position distal of thestroke begin position. As the displacement member translates distally,the closure member 764 with a cutting element positioned at a distalend, may cut the tissue between the ultrasonic blade 768 and the clamparm 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the closure member 764, for example, basedon one or more tissue conditions. The control circuit 760 may beprogrammed to sense tissue conditions, such as thickness, eitherdirectly or indirectly, as described herein. The control circuit 760 maybe programmed to select a control program based on tissue conditions. Acontrol program may describe the distal motion of the displacementmember. Different control programs may be selected to better treatdifferent tissue conditions. For example, when thicker tissue ispresent, the control circuit 760 may be programmed to translate thedisplacement member at a lower velocity and/or with lower power. Whenthinner tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a higher velocity and/or withhigher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 17 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the closure member764. The surgical instrument 790 comprises an end effector 792 that maycomprise a clamp arm 766, a closure member 764, and an ultrasonic blade768 which may be interchanged with or work in conjunction with one ormore RF electrodes 796 (shown in dashed line). The ultrasonic blade 768is coupled to an ultrasonic transducer 769 driven by an ultrasonicgenerator 771.

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In some examples, the position sensor 784 may be omitted. Where themotor 754 is a stepper motor, the control circuit 760 may track theposition of the closure member 764 by aggregating the number anddirection of steps that the motor has been instructed to execute. Theposition sensor 784 may be located in the end effector 792 or at anyother portion of the instrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF electrode 796 when the RF electrode 796 is provided inthe end effector 792 in place of the ultrasonic blade 768 or to work inconjunction with the ultrasonic blade 768. For example, the ultrasonicblade is made of electrically conductive metal and may be employed asthe return path for electrosurgical RF current. The control circuit 760controls the delivery of the RF energy to the RF electrode 796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

Generator Hardware Adaptive Ultrasonic Blade Control Algorithms

In various aspects smart ultrasonic energy devices may comprise adaptivealgorithms to control the operation of the ultrasonic blade. In oneaspect, the ultrasonic blade adaptive control algorithms are configuredto identify tissue type and adjust device parameters. In one aspect, theultrasonic blade control algorithms are configured to parameterizetissue type. An algorithm to detect the collagen/elastic ratio of tissueto tune the amplitude of the distal tip of the ultrasonic blade isdescribed in the following section of the present disclosure. Variousaspects of smart ultrasonic energy devices are described herein inconnection with FIGS. 1-37, for example. Accordingly, the followingdescription of adaptive ultrasonic blade control algorithms should beread in conjunction with FIGS. 1-37 and the description associatedtherewith.

Tissue Type Identification and Device Parameter Adjustments

In certain surgical procedures it would be desirable to employ adaptiveultrasonic blade control algorithms. In one aspect, adaptive ultrasonicblade control algorithms may be employed to adjust the parameters of theultrasonic device based on the type of tissue in contact with theultrasonic blade. In one aspect, the parameters of the ultrasonic devicemay be adjusted based on the location of the tissue within the jaws ofthe ultrasonic end effector, for example, the location of the tissuebetween the clamp arm and the ultrasonic blade. The impedance of theultrasonic transducer may be employed to differentiate what percentageof the tissue is located in the distal or proximal end of the endeffector. The reactions of the ultrasonic device may be based on thetissue type or compressibility of the tissue. In another aspect, theparameters of the ultrasonic device may be adjusted based on theidentified tissue type or parameterization. For example, the mechanicaldisplacement amplitude of the distal tip of the ultrasonic blade may betuned based on the ration of collagen to elastin tissue detected duringthe tissue identification procedure. The ratio of collagen to elastintissue may be detected used a variety of techniques including infrared(IR) surface reflectance and emissivity. The force applied to the tissueby the clamp arm and/or the stroke of the clamp arm to produce gap andcompression. Electrical continuity across a jaw equipped with electrodesmay be employed to determine what percentage of the jaw is covered withtissue.

FIG. 18 is a system 800 configured to execute adaptive ultrasonic bladecontrol algorithms in a surgical data network comprising a modularcommunication hub, in accordance with at least one aspect of the presentdisclosure. In one aspect, the generator module 240 is configured toexecute the adaptive ultrasonic blade control algorithm(s) 802 asdescribed in U.S. Provisional Patent Application No. 62/692,747, titledSMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on Jun.30, 2018, which is hereby incorporate by reference herein in itsentirety. In another aspect, the device/instrument 235 is configured toexecute the aforementioned adaptive ultrasonic blade controlalgorithm(s) 804, as described in U.S. Provisional Patent ApplicationNo. 62/692,747. In another aspect, both the device/instrument 235 andthe device/instrument 235 are configured to execute the aforementionedadaptive ultrasonic blade control algorithms 802, 804, as described inU.S. Provisional Patent Application No. 62/692,747.

The generator module 240 may comprise a patient isolated stage incommunication with a non-isolated stage via a power transformer. Asecondary winding of the power transformer is contained in the isolatedstage and may comprise a tapped configuration (e.g., a center-tapped ora non-center-tapped configuration) to define drive signal outputs fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, the drive signal outputs may output anultrasonic drive signal (e.g., a 420V root-mean-square (RMS) drivesignal) to an ultrasonic surgical instrument 241, and the drive signaloutputs may output an RF electrosurgical drive signal (e.g., a 100V RMSdrive signal) to an RF electrosurgical instrument 241. Aspects of thegenerator module 240 are described herein with reference to FIGS.19-26B.

The generator module 240 or the device/instrument 235 or both arecoupled to the modular control tower 236 connected to multiple operatingtheater devices such as, for example, intelligent surgical instruments,robots, and other computerized devices located in the operating theater,as described with reference to FIGS. 8-11, for example.

FIG. 19 illustrates an example of a generator 900, which is one form ofa generator configured to couple to an ultrasonic instrument and furtherconfigured to execute adaptive ultrasonic blade control algorithms in asurgical data network comprising a modular communication hub as shown inFIG. 18. The generator 900 is configured to deliver multiple energymodalities to a surgical instrument. The generator 900 provides RF andultrasonic signals for delivering energy to a surgical instrument eitherindependently or simultaneously. The RF and ultrasonic signals may beprovided alone or in combination and may be provided simultaneously. Asnoted above, at least one generator output can deliver multiple energymodalities (e.g., ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers) through a single port, and these signals can be deliveredseparately or simultaneously to the end effector to treat tissue. Thegenerator 900 comprises a processor 902 coupled to a waveform generator904. The processor 902 and waveform generator 904 are configured togenerate a variety of signal waveforms based on information stored in amemory coupled to the processor 902, not shown for clarity ofdisclosure. The digital information associated with a waveform isprovided to the waveform generator 904 which includes one or more DACcircuits to convert the digital input into an analog output. The analogoutput is fed to an amplifier 1106 for signal conditioning andamplification. The conditioned and amplified output of the amplifier 906is coupled to a power transformer 908. The signals are coupled acrossthe power transformer 908 to the secondary side, which is in the patientisolation side. A first signal of a first energy modality is provided tothe surgical instrument between the terminals labeled ENERGY₁ andRETURN. A second signal of a second energy modality is coupled across acapacitor 910 and is provided to the surgical instrument between theterminals labeled ENERGY₂ and RETURN. It will be appreciated that morethan two energy modalities may be output and thus the subscript “n” maybe used to designate that up to n ENERGY_(n) terminals may be provided,where n is a positive integer greater than 1. It also will beappreciated that up to “n” return paths RETURN_(n) may be providedwithout departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY₁ and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY₂ and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY₁/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY₂/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY₁ may be ultrasonic energy and the second energy modality ENERGY₂may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 19 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURN_(n) may beprovided for each energy modality ENERGY_(n). Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 19, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY₁ and RETURN as shown in FIG. 19. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY₂ and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY₂ output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to W-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), W-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

FIG. 20 illustrates one form of a surgical system 1000 comprising agenerator 1100 and various surgical instruments 1104, 1106, 1108 usabletherewith, where the surgical instrument 1104 is an ultrasonic surgicalinstrument, the surgical instrument 1106 is an RF electrosurgicalinstrument, and the multifunction surgical instrument 1108 is acombination ultrasonic/RF electrosurgical instrument. The generator 1100is configurable for use with a variety of surgical instruments.According to various forms, the generator 1100 may be configurable foruse with different surgical instruments of different types including,for example, ultrasonic surgical instruments 1104, RF electrosurgicalinstruments 1106, and multifunction surgical instruments 1108 thatintegrate RF and ultrasonic energies delivered simultaneously from thegenerator 1100. Although in the form of FIG. 20 the generator 1100 isshown separate from the surgical instruments 1104, 1106, 1108 in oneform, the generator 1100 may be formed integrally with any of thesurgical instruments 1104, 1106, 1108 to form a unitary surgical system.The generator 1100 comprises an input device 1110 located on a frontpanel of the generator 1100 console. The input device 1110 may compriseany suitable device that generates signals suitable for programming theoperation of the generator 1100. The generator 1100 may be configuredfor wired or wireless communication.

The generator 1100 is configured to drive multiple surgical instruments1104, 1106, 1108. The first surgical instrument is an ultrasonicsurgical instrument 1104 and comprises a handpiece 1105 (HP), anultrasonic transducer 1120, a shaft 1126, and an end effector 1122. Theend effector 1122 comprises an ultrasonic blade 1128 acousticallycoupled to the ultrasonic transducer 1120 and a clamp arm 1140. Thehandpiece 1105 comprises a trigger 1143 to operate the clamp arm 1140and a combination of the toggle buttons 1134 a, 1134 b, 1134 c toenergize and drive the ultrasonic blade 1128 or other function. Thetoggle buttons 1134 a, 1134 b, 1134 c can be configured to energize theultrasonic transducer 1120 with the generator 1100.

The generator 1100 also is configured to drive a second surgicalinstrument 1106. The second surgical instrument 1106 is an RFelectrosurgical instrument and comprises a handpiece 1107 (HP), a shaft1127, and an end effector 1124. The end effector 1124 compriseselectrodes in clamp arms 1142 a, 1142 b and return through an electricalconductor portion of the shaft 1127. The electrodes are coupled to andenergized by a bipolar energy source within the generator 1100. Thehandpiece 1107 comprises a trigger 1145 to operate the clamp arms 1142a, 1142 b and an energy button 1135 to actuate an energy switch toenergize the electrodes in the end effector 1124.

The generator 1100 also is configured to drive a multifunction surgicalinstrument 1108. The multifunction surgical instrument 1108 comprises ahandpiece 1109 (HP), a shaft 1129, and an end effector 1125. The endeffector 1125 comprises an ultrasonic blade 1149 and a clamp arm 1146.The ultrasonic blade 1149 is acoustically coupled to the ultrasonictransducer 1120. The handpiece 1109 comprises a trigger 1147 to operatethe clamp arm 1146 and a combination of the toggle buttons 1137 a, 1137b, 1137 c to energize and drive the ultrasonic blade 1149 or otherfunction. The toggle buttons 1137 a, 1137 b, 1137 c can be configured toenergize the ultrasonic transducer 1120 with the generator 1100 andenergize the ultrasonic blade 1149 with a bipolar energy source alsocontained within the generator 1100.

The generator 1100 is configurable for use with a variety of surgicalinstruments. According to various forms, the generator 1100 may beconfigurable for use with different surgical instruments of differenttypes including, for example, the ultrasonic surgical instrument 1104,the RF electrosurgical instrument 1106, and the multifunction surgicalinstrument 1108 that integrates RF and ultrasonic energies deliveredsimultaneously from the generator 1100. Although in the form of FIG. 20the generator 1100 is shown separate from the surgical instruments 1104,1106, 1108, in another form the generator 1100 may be formed integrallywith any one of the surgical instruments 1104, 1106, 1108 to form aunitary surgical system. As discussed above, the generator 1100comprises an input device 1110 located on a front panel of the generator1100 console. The input device 1110 may comprise any suitable devicethat generates signals suitable for programming the operation of thegenerator 1100. The generator 1100 also may comprise one or more outputdevices 1112. Further aspects of generators for digitally generatingelectrical signal waveforms and surgical instruments are described in USpatent publication US-2017-0086914-A1, which is herein incorporated byreference in its entirety.

FIG. 21 is an end effector 1122 of the example ultrasonic device 1104,in accordance with at least one aspect of the present disclosure. Theend effector 1122 may comprise a blade 1128 that may be coupled to theultrasonic transducer 1120 via a wave guide. When driven by theultrasonic transducer 1120, the blade 1128 may vibrate and, when broughtinto contact with tissue, may cut and/or coagulate the tissue, asdescribed herein. According to various aspects, and as illustrated inFIG. 21, the end effector 1122 may also comprise a clamp arm 1140 thatmay be configured for cooperative action with the blade 1128 of the endeffector 1122. With the blade 1128, the clamp arm 1140 may comprise aset of jaws. The clamp arm 1140 may be pivotally connected at a distalend of a shaft 1126 of the instrument portion 1104. The clamp arm 1140may include a clamp arm tissue pad 1163, which may be formed fromTEFLON® or other suitable low-friction material. The pad 1163 may bemounted for cooperation with the blade 1128, with pivotal movement ofthe clamp arm 1140 positioning the clamp pad 1163 in substantiallyparallel relationship to, and in contact with, the blade 1128. By thisconstruction, a tissue bite to be clamped may be grasped between thetissue pad 1163 and the blade 1128. The tissue pad 1163 may be providedwith a sawtooth-like configuration including a plurality of axiallyspaced, proximally extending gripping teeth 1161 to enhance the grippingof tissue in cooperation with the blade 1128. The clamp arm 1140 maytransition from the open position shown in FIG. 21 to a closed position(with the clamp arm 1140 in contact with or proximity to the blade 1128)in any suitable manner. For example, the handpiece 1105 may comprise ajaw closure trigger. When actuated by a clinician, the jaw closuretrigger may pivot the clamp arm 1140 in any suitable manner.

The generator 1100 may be activated to provide the drive signal to theultrasonic transducer 1120 in any suitable manner. For example, thegenerator 1100 may comprise a foot switch 1430 (FIG. 22) coupled to thegenerator 1100 via a footswitch cable 1432. A clinician may activate theultrasonic transducer 1120, and thereby the ultrasonic transducer 1120and blade 1128, by depressing the foot switch 1430. In addition, orinstead of the foot switch 1430, some aspects of the device 1104 mayutilize one or more switches positioned on the handpiece 1105 that, whenactivated, may cause the generator 1100 to activate the ultrasonictransducer 1120. In one aspect, for example, the one or more switchesmay comprise a pair of toggle buttons 1134 a, 1134 b, 1134 c (FIG. 20),for example, to determine an operating mode of the device 1104. When thetoggle button 1134 a is depressed, for example, the ultrasonic generator1100 may provide a maximum drive signal to the ultrasonic transducer1120, causing it to produce maximum ultrasonic energy output. Depressingtoggle button 1134 b may cause the ultrasonic generator 1100 to providea user-selectable drive signal to the ultrasonic transducer 1120,causing it to produce less than the maximum ultrasonic energy output.The device 1104 additionally or alternatively may comprise a secondswitch to, for example, indicate a position of a jaw closure trigger foroperating the jaws via the clamp arm 1140 of the end effector 1122.Also, in some aspects, the ultrasonic generator 1100 may be activatedbased on the position of the jaw closure trigger, (e.g., as theclinician depresses the jaw closure trigger to close the jaws via theclamp arm 1140, ultrasonic energy may be applied).

Additionally or alternatively, the one or more switches may comprise atoggle button 1134 c that, when depressed, causes the generator 1100 toprovide a pulsed output (FIG. 20). The pulses may be provided at anysuitable frequency and grouping, for example. In certain aspects, thepower level of the pulses may be the power levels associated with togglebuttons 1134 a, 1134 b (maximum, less than maximum), for example.

It will be appreciated that a device 1104 may comprise any combinationof the toggle buttons 1134 a, 1134 b, 1134 c (FIG. 20). For example, thedevice 1104 could be configured to have only two toggle buttons: atoggle button 1134 a for producing maximum ultrasonic energy output anda toggle button 1134 c for producing a pulsed output at either themaximum or less than maximum power level per. In this way, the drivesignal output configuration of the generator 1100 could be fivecontinuous signals, or any discrete number of individual pulsed signals(1, 2, 3, 4, or 5). In certain aspects, the specific drive signalconfiguration may be controlled based upon, for example, EEPROM settingsin the generator 1100 and/or user power level selection(s).

In certain aspects, a two-position switch may be provided as analternative to a toggle button 1134 c (FIG. 20). For example, a device1104 may include a toggle button 1134 a for producing a continuousoutput at a maximum power level and a two-position toggle button 1134 b.In a first detented position, toggle button 1134 b may produce acontinuous output at a less than maximum power level, and in a seconddetented position the toggle button 1134 b may produce a pulsed output(e.g., at either a maximum or less than maximum power level, dependingupon the EEPROM settings).

In some aspects, the RF electrosurgical end effector 1124, 1125 (FIG.20) may also comprise a pair of electrodes. The electrodes may be incommunication with the generator 1100, for example, via a cable. Theelectrodes may be used, for example, to measure an impedance of a tissuebite present between the clamp arm 1142 a, 1146 and the blade 1142 b,1149. The generator 1100 may provide a signal (e.g., a non-therapeuticsignal) to the electrodes. The impedance of the tissue bite may befound, for example, by monitoring the current, voltage, etc. of thesignal.

In various aspects, the generator 1100 may comprise several separatefunctional elements, such as modules and/or blocks, as shown in FIG. 22,a diagram of the surgical system 1000 of FIG. 20. Different functionalelements or modules may be configured for driving the different kinds ofsurgical devices 1104, 1106, 1108. For example an ultrasonic generatormodule may drive an ultrasonic device, such as the ultrasonic device1104. An electrosurgery/RF generator module may drive theelectrosurgical device 1106. The modules may generate respective drivesignals for driving the surgical devices 1104, 1106, 1108. In variousaspects, the ultrasonic generator module and/or the electrosurgery/RFgenerator module each may be formed integrally with the generator 1100.Alternatively, one or more of the modules may be provided as a separatecircuit module electrically coupled to the generator 1100. (The modulesare shown in phantom to illustrate this option.) Also, in some aspects,the electrosurgery/RF generator module may be formed integrally with theultrasonic generator module, or vice versa.

In accordance with the described aspects, the ultrasonic generatormodule may produce a drive signal or signals of particular voltages,currents, and frequencies (e.g. 55,500 cycles per second, or Hz). Thedrive signal or signals may be provided to the ultrasonic device 1104,and specifically to the transducer 1120, which may operate, for example,as described above. In one aspect, the generator 1100 may be configuredto produce a drive signal of a particular voltage, current, and/orfrequency output signal that can be stepped with high resolution,accuracy, and repeatability.

In accordance with the described aspects, the electrosurgery/RFgenerator module may generate a drive signal or signals with outputpower sufficient to perform bipolar electrosurgery using radio frequency(RF) energy. In bipolar electrosurgery applications, the drive signalmay be provided, for example, to the electrodes of the electrosurgicaldevice 1106, for example, as described above. Accordingly, the generator1100 may be configured for therapeutic purposes by applying electricalenergy to the tissue sufficient for treating the tissue (e.g.,coagulation, cauterization, tissue welding, etc.).

The generator 1100 may comprise an input device 2150 (FIG. 25B) located,for example, on a front panel of the generator 1100 console. The inputdevice 2150 may comprise any suitable device that generates signalssuitable for programming the operation of the generator 1100. Inoperation, the user can program or otherwise control operation of thegenerator 1100 using the input device 2150. The input device 2150 maycomprise any suitable device that generates signals that can be used bythe generator (e.g., by one or more processors contained in thegenerator) to control the operation of the generator 1100 (e.g.,operation of the ultrasonic generator module and/or electrosurgery/RFgenerator module). In various aspects, the input device 2150 includesone or more of: buttons, switches, thumbwheels, keyboard, keypad, touchscreen monitor, pointing device, remote connection to a general purposeor dedicated computer. In other aspects, the input device 2150 maycomprise a suitable user interface, such as one or more user interfacescreens displayed on a touch screen monitor, for example. Accordingly,by way of the input device 2150, the user can set or program variousoperating parameters of the generator, such as, for example, current(I), voltage (V), frequency (f), and/or period (T) of a drive signal orsignals generated by the ultrasonic generator module and/orelectrosurgery/RF generator module.

The generator 1100 may also comprise an output device 2140 (FIG. 25B)located, for example, on a front panel of the generator 1100 console.The output device 2140 includes one or more devices for providing asensory feedback to a user. Such devices may comprise, for example,visual feedback devices (e.g., an LCD display screen, LED indicators),audio feedback devices (e.g., a speaker, a buzzer) or tactile feedbackdevices (e.g., haptic actuators).

Although certain modules and/or blocks of the generator 1100 may bedescribed by way of example, it can be appreciated that a greater orlesser number of modules and/or blocks may be used and still fall withinthe scope of the aspects. Further, although various aspects may bedescribed in terms of modules and/or blocks to facilitate description,such modules and/or blocks may be implemented by one or more hardwarecomponents, e.g., processors, Digital Signal Processors (DSPs),Programmable Logic Devices (PLDs), Application Specific IntegratedCircuits (ASICs), circuits, registers and/or software components, e.g.,programs, subroutines, logic and/or combinations of hardware andsoftware components.

In one aspect, the ultrasonic generator drive module andelectrosurgery/RF drive module 1110 (FIG. 20) may comprise one or moreembedded applications implemented as firmware, software, hardware, orany combination thereof. The modules may comprise various executablemodules such as software, programs, data, drivers, application programinterfaces (APIs), and so forth. The firmware may be stored innonvolatile memory (NVM), such as in bit-masked read-only memory (ROM)or flash memory. In various implementations, storing the firmware in ROMmay preserve flash memory. The NVM may comprise other types of memoryincluding, for example, programmable ROM (PROM), erasable programmableROM (EPROM), electrically erasable programmable ROM (EEPROM), or batterybacked random-access memory (RAM) such as dynamic RAM (DRAM),Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).

In one aspect, the modules comprise a hardware component implemented asa processor for executing program instructions for monitoring variousmeasurable characteristics of the devices 1104, 1106, 1108 andgenerating a corresponding output drive signal or signals for operatingthe devices 1104, 1106, 1108. In aspects in which the generator 1100 isused in conjunction with the device 1104, the drive signal may drive theultrasonic transducer 1120 in cutting and/or coagulation operatingmodes. Electrical characteristics of the device 1104 and/or tissue maybe measured and used to control operational aspects of the generator1100 and/or provided as feedback to the user. In aspects in which thegenerator 1100 is used in conjunction with the device 1106, the drivesignal may supply electrical energy (e.g., RF energy) to the endeffector 1124 in cutting, coagulation and/or desiccation modes.Electrical characteristics of the device 1106 and/or tissue may bemeasured and used to control operational aspects of the generator 1100and/or provided as feedback to the user. In various aspects, aspreviously discussed, the hardware components may be implemented as DSP,PLD, ASIC, circuits, and/or registers. In one aspect, the processor maybe configured to store and execute computer software programinstructions to generate the step function output signals for drivingvarious components of the devices 1104, 1106, 1108, such as theultrasonic transducer 1120 and the end effectors 1122, 1124, 1125.

An electromechanical ultrasonic system includes an ultrasonictransducer, a waveguide, and an ultrasonic blade. The electromechanicalultrasonic system has an initial resonant frequency defined by thephysical properties of the ultrasonic transducer, the waveguide, and theultrasonic blade. The ultrasonic transducer is excited by an alternatingvoltage V_(g)(t) and current I_(g)(t) signal equal to the resonantfrequency of the electromechanical ultrasonic system. When theelectromechanical ultrasonic system is at resonance, the phasedifference between the voltage V_(g)(t) and current I_(g)(t) signals iszero. Stated another way, at resonance the inductive impedance is equalto the capacitive impedance. As the ultrasonic blade heats up, thecompliance of the ultrasonic blade (modeled as an equivalentcapacitance) causes the resonant frequency of the electromechanicalultrasonic system to shift. Thus, the inductive impedance is no longerequal to the capacitive impedance causing a mismatch between the drivefrequency and the resonant frequency of the electromechanical ultrasonicsystem. The system is now operating “off-resonance.” The mismatchbetween the drive frequency and the resonant frequency is manifested asa phase difference between the voltage V_(g)(t) and current I_(g)(t)signals applied to the ultrasonic transducer. The generator electronicscan easily monitor the phase difference between the voltage V_(g)(t) andcurrent I_(g)(t) signals and can continuously adjust the drive frequencyuntil the phase difference is once again zero. At this point, the newdrive frequency is equal to the new resonant frequency of theelectromechanical ultrasonic system. The change in phase and/orfrequency can be used as an indirect measurement of the ultrasonic bladetemperature.

As shown in FIG. 23, the electromechanical properties of the ultrasonictransducer may be modeled as an equivalent circuit comprising a firstbranch having a static capacitance and a second “motional” branch havinga serially connected inductance, resistance and capacitance that definethe electromechanical properties of a resonator. Known ultrasonicgenerators may include a tuning inductor for tuning out the staticcapacitance at a resonant frequency so that substantially all ofgenerator's drive signal current flows into the motional branch.Accordingly, by using a tuning inductor, the generator's drive signalcurrent represents the motional branch current, and the generator isthus able to control its drive signal to maintain the ultrasonictransducer's resonant frequency. The tuning inductor may also transformthe phase impedance plot of the ultrasonic transducer to improve thegenerator's frequency lock capabilities. However, the tuning inductormust be matched with the specific static capacitance of an ultrasonictransducer at the operational resonance frequency. In other words, adifferent ultrasonic transducer having a different static capacitancerequires a different tuning inductor.

FIG. 23 illustrates an equivalent circuit 1500 of an ultrasonictransducer, such as the ultrasonic transducer 1120, according to oneaspect. The circuit 1500 comprises a first “motional” branch having aserially connected inductance L_(s), resistance R_(s) and capacitanceC_(s) that define the electromechanical properties of the resonator, anda second capacitive branch having a static capacitance C₀. Drive currentI_(g)(t) may be received from a generator at a drive voltage V_(g)(t),with motional current I_(m)(t) flowing through the first branch andcurrent I_(g)(t)-I_(m)(t) flowing through the capacitive branch. Controlof the electromechanical properties of the ultrasonic transducer may beachieved by suitably controlling I_(g)(t) and V_(g)(t). As explainedabove, known generator architectures may include a tuning inductor L_(t)(shown in phantom in FIG. 23) in a parallel resonance circuit for tuningout the static capacitance C₀ at a resonant frequency so thatsubstantially all of the generator's current output I_(g)(t) flowsthrough the motional branch. In this way, control of the motional branchcurrent I_(m)(t) is achieved by controlling the generator current outputI_(g)(t). The tuning inductor L_(t) is specific to the staticcapacitance C₀ of an ultrasonic transducer, however, and a differentultrasonic transducer having a different static capacitance requires adifferent tuning inductor L_(t). Moreover, because the tuning inductorL_(t) is matched to the nominal value of the static capacitance C₀ at asingle resonant frequency, accurate control of the motional branchcurrent I_(m)(t) is assured only at that frequency. As frequency shiftsdown with transducer temperature, accurate control of the motionalbranch current is compromised.

Various aspects of the generator 1100 may not rely on a tuning inductorL_(t) to monitor the motional branch current I_(m)(t). Instead, thegenerator 1100 may use the measured value of the static capacitance C₀in between applications of power for a specific ultrasonic surgicaldevice 1104 (along with drive signal voltage and current feedback data)to determine values of the motional branch current I_(m)(t) on a dynamicand ongoing basis (e.g., in real-time). Such aspects of the generator1100 are therefore able to provide virtual tuning to simulate a systemthat is tuned or resonant with any value of static capacitance C₀ at anyfrequency, and not just at a single resonant frequency dictated by anominal value of the static capacitance C₀.

FIG. 24 is a simplified block diagram of one aspect of the generator1100 for providing inductorless tuning as described above, among otherbenefits. FIGS. 25A-25C illustrate an architecture of the generator 1100of FIG. 24 according to one aspect. With reference to FIG. 24, thegenerator 1100 may comprise a patient isolated stage 1520 incommunication with a non-isolated stage 1540 via a power transformer1560. A secondary winding 1580 of the power transformer 1560 iscontained in the isolated stage 1520 and may comprise a tappedconfiguration (e.g., a center-tapped or non-center tapped configuration)to define drive signal outputs 1600 a, 1600 b, 1600 c for outputtingdrive signals to different surgical devices, such as, for example, anultrasonic surgical device 1104 and an electrosurgical device 1106. Inparticular, drive signal outputs 1600 a, 1600 b, 1600 c may output adrive signal (e.g., a 420V RMS drive signal) to an ultrasonic surgicaldevice 1104, and drive signal outputs 1600 a, 1600 b, 1600 c may outputa drive signal (e.g., a 100V RMS drive signal) to an electrosurgicaldevice 1106, with output 1600 b corresponding to the center tap of thepower transformer 1560. The non-isolated stage 1540 may comprise a poweramplifier 1620 having an output connected to a primary winding 1640 ofthe power transformer 1560. In certain aspects the power amplifier 1620may comprise a push-pull amplifier, for example. The non-isolated stage1540 may further comprise a programmable logic device 1660 for supplyinga digital output to a digital-to-analog converter (DAC) 1680, which inturn supplies a corresponding analog signal to an input of the poweramplifier 1620. In certain aspects the programmable logic device 1660may comprise a field-programmable gate array (FPGA), for example. Theprogrammable logic device 1660, by virtue of controlling the poweramplifier's 1620 input via the DAC 1680, may therefore control any of anumber of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 1600a, 1600 b, 1600 c. In certain aspects and as discussed below, theprogrammable logic device 1660, in conjunction with a processor (e.g.,processor 1740 discussed below), may implement a number of digitalsignal processing (DSP)-based and/or other control algorithms to controlparameters of the drive signals output by the generator 1100.

Power may be supplied to a power rail of the power amplifier 1620 by aswitch-mode regulator 1700. In certain aspects the switch-mode regulator1700 may comprise an adjustable buck regulator, for example. Asdiscussed above, the non-isolated stage 1540 may further comprise aprocessor 1740, which in one aspect may comprise a DSP processor such asan ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass.,for example. In certain aspects the processor 1740 may control operationof the switch-mode power converter 1700 responsive to voltage feedbackdata received from the power amplifier 1620 by the processor 1740 via ananalog-to-digital converter (ADC) 1760. In one aspect, for example, theprocessor 1740 may receive as input, via the ADC 1760, the waveformenvelope of a signal (e.g., an RF signal) being amplified by the poweramplifier 1620. The processor 1740 may then control the switch-moderegulator 1700 (e.g., via a pulse-width modulated (PWM) output) suchthat the rail voltage supplied to the power amplifier 1620 tracks thewaveform envelope of the amplified signal. By dynamically modulating therail voltage of the power amplifier 1620 based on the waveform envelope,the efficiency of the power amplifier 1620 may be significantly improvedrelative to a fixed rail voltage amplifier scheme. The processor 1740may be configured for wired or wireless communication.

In certain aspects and as discussed in further detail in connection withFIGS. 26A-26B, the programmable logic device 1660, in conjunction withthe processor 1740, may implement a direct digital synthesizer (DDS)control scheme to control the waveform shape, frequency and/or amplitudeof drive signals output by the generator 1100. In one aspect, forexample, the programmable logic device 1660 may implement a DDS controlalgorithm 2680 (FIG. 26A) by recalling waveform samples stored in adynamically-updated look-up table (LUT), such as a RAM LUT which may beembedded in an FPGA. This control algorithm is particularly useful forultrasonic applications in which an ultrasonic transducer, such as theultrasonic transducer 1120, may be driven by a clean sinusoidal currentat its resonant frequency. Because other frequencies may exciteparasitic resonances, minimizing or reducing the total distortion of themotional branch current may correspondingly minimize or reduceundesirable resonance effects. Because the waveform shape of a drivesignal output by the generator 1100 is impacted by various sources ofdistortion present in the output drive circuit (e.g., the powertransformer 1560, the power amplifier 1620), voltage and currentfeedback data based on the drive signal may be input into an algorithm,such as an error control algorithm implemented by the processor 1740,which compensates for distortion by suitably pre-distorting or modifyingthe waveform samples stored in the LUT on a dynamic, ongoing basis(e.g., in real-time). In one aspect, the amount or degree ofpre-distortion applied to the LUT samples may be based on the errorbetween a computed motional branch current and a desired currentwaveform shape, with the error being determined on a sample-by samplebasis. In this way, the pre-distorted LUT samples, when processedthrough the drive circuit, may result in a motional branch drive signalhaving the desired waveform shape (e.g., sinusoidal) for optimallydriving the ultrasonic transducer. In such aspects, the LUT waveformsamples will therefore not represent the desired waveform shape of thedrive signal, but rather the waveform shape that is required toultimately produce the desired waveform shape of the motional branchdrive signal when distortion effects are taken into account.

The non-isolated stage 1540 may further comprise an ADC 1780 and an ADC1800 coupled to the output of the power transformer 1560 via respectiveisolation transformers 1820, 1840 for respectively sampling the voltageand current of drive signals output by the generator 1100. In certainaspects, the ADCs 1780, 1800 may be configured to sample at high speeds(e.g., 80 Msps) to enable oversampling of the drive signals. In oneaspect, for example, the sampling speed of the ADCs 1780, 1800 mayenable approximately 200× (depending on drive frequency) oversampling ofthe drive signals. In certain aspects, the sampling operations of theADCs 1780, 1800 may be performed by a single ADC receiving input voltageand current signals via a two-way multiplexer. The use of high-speedsampling in aspects of the generator 1100 may enable, among otherthings, calculation of the complex current flowing through the motionalbranch (which may be used in certain aspects to implement DDS-basedwaveform shape control described above), accurate digital filtering ofthe sampled signals, and calculation of real power consumption with ahigh degree of precision. Voltage and current feedback data output bythe ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering,multiplexing) by the programmable logic device 1660 and stored in datamemory for subsequent retrieval by, for example, the processor 1740. Asnoted above, voltage and current feedback data may be used as input toan algorithm for pre-distorting or modifying LUT waveform samples on adynamic and ongoing basis. In certain aspects, this may require eachstored voltage and current feedback data pair to be indexed based on, orotherwise associated with, a corresponding LUT sample that was output bythe programmable logic device 1660 when the voltage and current feedbackdata pair was acquired. Synchronization of the LUT samples and thevoltage and current feedback data in this manner contributes to thecorrect timing and stability of the pre-distortion algorithm.

In certain aspects, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one aspect, for example, voltage and current feedbackdata may be used to determine impedance phase, e.g., the phasedifference between the voltage and current drive signals. The frequencyof the drive signal may then be controlled to minimize or reduce thedifference between the determined impedance phase and an impedance phasesetpoint (e.g., 0°), thereby minimizing or reducing the effects ofharmonic distortion and correspondingly enhancing impedance phasemeasurement accuracy. The determination of phase impedance and afrequency control signal may be implemented in the processor 1740, forexample, with the frequency control signal being supplied as input to aDDS control algorithm implemented by the programmable logic device 1660.

The impedance phase may be determined through Fourier analysis. In oneaspect, the phase difference between the generator voltage V_(g)(t) andgenerator current I_(g)(t) driving signals may be determined using theFast Fourier Transform (FFT) or the Discrete Fourier Transform (DFT) asfollows:

V_(g)(t) = A₁cos (2π f₀t + ϕ₁)I_(g)(t) = A₂cos (2π f₀t + ϕ₂)${V_{g}(f)} = {\frac{A_{1}}{2}\left( {{\delta \left( {f - f_{0}} \right)} + {\delta \left( {f + f_{0}} \right)}} \right){\exp \left( {j\; 2\pi \; f\frac{\phi_{1}}{2\pi \; f_{0}}} \right)}}$${I_{g}(f)} = {\frac{A_{2}}{2}\left( {{\delta \left( {f - f_{0}} \right)} + {\delta \left( {f + f_{0}} \right)}} \right){\exp \left( {j\; 2\pi \; f\frac{\phi_{2}}{2\pi \; f_{0}}} \right)}}$

Evaluating the Fourier Transform at the frequency of the sinusoidyields:

${V_{g}\left( f_{0} \right)} = {{\frac{A_{1}}{2}{\delta (0)}{\exp \left( {j\; \phi_{1}} \right)}\arg \; {V\left( f_{0} \right)}} = \phi_{1}}$${I_{g}\left( f_{0} \right)} = {{\frac{A_{2}}{2}{\delta (0)}{\exp \left( {j\; \phi_{2}} \right)}\arg \; {I\left( f_{0} \right)}} = \phi_{2}}$

Other approaches include weighted least-squares estimation, Kalmanfiltering, and space-vector-based techniques. Virtually all of theprocessing in an FFT or DFT technique may be performed in the digitaldomain with the aid of the 2-channel high speed ADC 1780, 1800, forexample. In one technique, the digital signal samples of the voltage andcurrent signals are Fourier transformed with an FFT or a DFT. The phaseangle φ at any point in time can be calculated by:

φ=2πft+φ ₀

Where φ is the phase angle, f is the frequency, t is time, and φ₀ is thephase at t=0.

Another technique for determining the phase difference between thevoltage V_(g)(t) and current I_(g)(t) signals is the zero-crossingmethod and produces highly accurate results. For voltage V_(g)(t) andcurrent I_(g)(t) signals having the same frequency, each negative topositive zero-crossing of voltage signal V_(g)(t) triggers the start ofa pulse, while each negative to positive zero-crossing of current signalI_(g)(t) triggers the end of the pulse. The result is a pulse train witha pulse width proportional to the phase angle between the voltage signaland the current signal. In one aspect, the pulse train may be passedthrough an averaging filter to yield a measure of the phase difference.Furthermore, if the positive to negative zero crossings also are used ina similar manner, and the results averaged, any effects of DC andharmonic components can be reduced. In one implementation, the analogvoltage V_(g)(t) and current I_(g)(t) signals are converted to digitalsignals that are high if the analog signal is positive and low if theanalog signal is negative. High accuracy phase estimates require sharptransitions between high and low. In one aspect, a Schmitt trigger alongwith an RC stabilization network may be employed to convert the analogsignals into digital signals. In other aspects, an edge triggered RSflip-flop and ancillary circuitry may be employed. In yet anotheraspect, the zero-crossing technique may employ an eXclusive OR (XOR)gate.

Other techniques for determining the phase difference between thevoltage and current signals include Lissajous figures and monitoring theimage; methods such as the three-voltmeter method, the crossed-coilmethod, vector voltmeter and vector impedance methods; and using phasestandard instruments, phase-locked loops, and other techniques asdescribed in Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http://www.engnetbase.com>, which is incorporated herein by reference.

In another aspect, for example, the current feedback data may bemonitored in order to maintain the current amplitude of the drive signalat a current amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain aspects, control of thecurrent amplitude may be implemented by control algorithm, such as, forexample, a proportional-integral-derivative (PID) control algorithm, inthe processor 1740. Variables controlled by the control algorithm tosuitably control the current amplitude of the drive signal may include,for example, the scaling of the LUT waveform samples stored in theprogrammable logic device 1660 and/or the full-scale output voltage ofthe DAC 1680 (which supplies the input to the power amplifier 1620) viaa DAC 1860.

The non-isolated stage 1540 may further comprise a processor 1900 forproviding, among other things, user interface (UI) functionality. In oneaspect, the processor 1900 may comprise an Atmel AT91 SAM9263 processorhaving an ARM 926EJ-S core, available from Atmel Corporation, San Jose,Calif., for example. Examples of UI functionality supported by theprocessor 1900 may include audible and visual user feedback,communication with peripheral devices (e.g., via a Universal Serial Bus(USB) interface), communication with a foot switch 1430, communicationwith an input device 2150 (e.g., a touch screen display) andcommunication with an output device 2140 (e.g., a speaker). Theprocessor 1900 may communicate with the processor 1740 and theprogrammable logic device (e.g., via a serial peripheral interface (SPI)bus). Although the processor 1900 may primarily support UIfunctionality, it may also coordinate with the processor 1740 toimplement hazard mitigation in certain aspects. For example, theprocessor 1900 may be programmed to monitor various aspects of userinput and/or other inputs (e.g., touch screen inputs 2150, foot switch1430 inputs, temperature sensor inputs 2160) and may disable the driveoutput of the generator 1100 when an erroneous condition is detected.

In certain aspects, both the processor 1740 (FIG. 24, 25A) and theprocessor 1900 (FIG. 24, 25B) may determine and monitor the operatingstate of the generator 1100. For processor 1740, the operating state ofthe generator 1100 may dictate, for example, which control and/ordiagnostic processes are implemented by the processor 1740. Forprocessor 1900, the operating state of the generator 1100 may dictate,for example, which elements of a user interface (e.g., display screens,sounds) are presented to a user. The processors 1740, 1900 mayindependently maintain the current operating state of the generator 1100and recognize and evaluate possible transitions out of the currentoperating state. The processor 1740 may function as the master in thisrelationship and determine when transitions between operating states areto occur. The processor 1900 may be aware of valid transitions betweenoperating states and may confirm if a particular transition isappropriate. For example, when the processor 1740 instructs theprocessor 1900 to transition to a specific state, the processor 1900 mayverify that the requested transition is valid. In the event that arequested transition between states is determined to be invalid by theprocessor 1900, the processor 1900 may cause the generator 1100 to entera failure mode.

The non-isolated stage 1540 may further comprise a controller 1960 (FIG.24, 25B) for monitoring input devices 2150 (e.g., a capacitive touchsensor used for turning the generator 1100 on and off, a capacitivetouch screen). In certain aspects, the controller 1960 may comprise atleast one processor and/or other controller device in communication withthe processor 1900. In one aspect, for example, the controller 1960 maycomprise a processor (e.g., a Mega168 8-bit controller available fromAtmel) configured to monitor user input provided via one or morecapacitive touch sensors. In one aspect, the controller 1960 maycomprise a touch screen controller (e.g., a QT5480 touch screencontroller available from Atmel) to control and manage the acquisitionof touch data from a capacitive touch screen.

In certain aspects, when the generator 1100 is in a “power off” state,the controller 1960 may continue to receive operating power (e.g., via aline from a power supply of the generator 1100, such as the power supply2110 (FIG. 24) discussed below). In this way, the controller 1960 maycontinue to monitor an input device 2150 (e.g., a capacitive touchsensor located on a front panel of the generator 1100) for turning thegenerator 1100 on and off. When the generator 1100 is in the “power off”state, the controller 1960 may wake the power supply (e.g., enableoperation of one or more DC/DC voltage converters 2130 (FIG. 24) of thepower supply 2110) if activation of the “on/off” input device 2150 by auser is detected. The controller 1960 may therefore initiate a sequencefor transitioning the generator 1100 to a “power on” state. Conversely,the controller 1960 may initiate a sequence for transitioning thegenerator 1100 to the “power off” state if activation of the “on/off”input device 2150 is detected when the generator 1100 is in the “poweron” state. In certain aspects, for example, the controller 1960 mayreport activation of the “on/off” input device 2150 to the processor1900, which in turn implements the necessary process sequence fortransitioning the generator 1100 to the “power off” state. In suchaspects, the controller 1960 may have no independent ability for causingthe removal of power from the generator 1100 after its “power on” statehas been established.

In certain aspects, the controller 1960 may cause the generator 1100 toprovide audible or other sensory feedback for alerting the user that a“power on” or “power off” sequence has been initiated. Such an alert maybe provided at the beginning of a “power on” or “power off” sequence andprior to the commencement of other processes associated with thesequence.

In certain aspects, the isolated stage 1520 may comprise an instrumentinterface circuit 1980 to, for example, provide a communicationinterface between a control circuit of a surgical device (e.g., acontrol circuit comprising handpiece switches) and components of thenon-isolated stage 1540, such as, for example, the programmable logicdevice 1660, the processor 1740 and/or the processor 1900. Theinstrument interface circuit 1980 may exchange information withcomponents of the non-isolated stage 1540 via a communication link thatmaintains a suitable degree of electrical isolation between the stages1520, 1540, such as, for example, an infrared (IR)-based communicationlink. Power may be supplied to the instrument interface circuit 1980using, for example, a low-dropout voltage regulator powered by anisolation transformer driven from the non-isolated stage 1540.

In one aspect, the instrument interface circuit 1980 may comprise aprogrammable logic device 2000 (e.g., an FPGA) in communication with asignal conditioning circuit 2020 (FIG. 24 and FIG. 25C). The signalconditioning circuit 2020 may be configured to receive a periodic signalfrom the programmable logic device 2000 (e.g., a 2 kHz square wave) togenerate a bipolar interrogation signal having an identical frequency.The interrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical device control circuit (e.g., by usinga conductive pair in a cable that connects the generator 1100 to thesurgical device) and monitored to determine a state or configuration ofthe control circuit. For example, the control circuit may comprise anumber of switches, resistors and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernible based on the one or more characteristics. In oneaspect, for example, the signal conditioning circuit 2020 may comprisean ADC for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The programmable logic device 2000 (or a componentof the non-isolated stage 1540) may then determine the state orconfiguration of the control circuit based on the ADC samples.

In one aspect, the instrument interface circuit 1980 may comprise afirst data circuit interface 2040 to enable information exchange betweenthe programmable logic device 2000 (or other element of the instrumentinterface circuit 1980) and a first data circuit disposed in orotherwise associated with a surgical device. In certain aspects, forexample, a first data circuit 2060 may be disposed in a cable integrallyattached to a surgical device handpiece, or in an adaptor forinterfacing a specific surgical device type or model with the generator1100. In certain aspects, the first data circuit may comprise anon-volatile storage device, such as an electrically erasableprogrammable read-only memory (EEPROM) device. In certain aspects andreferring again to FIG. 24, the first data circuit interface 2040 may beimplemented separately from the programmable logic device 2000 andcomprise suitable circuitry (e.g., discrete logic devices, a processor)to enable communication between the programmable logic device 2000 andthe first data circuit. In other aspects, the first data circuitinterface 2040 may be integral with the programmable logic device 2000.

In certain aspects, the first data circuit 2060 may store informationpertaining to the particular surgical device with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical device hasbeen used, and/or any other type of information. This information may beread by the instrument interface circuit 1980 (e.g., by the programmablelogic device 2000), transferred to a component of the non-isolated stage1540 (e.g., to programmable logic device 1660, processor 1740 and/orprocessor 1900) for presentation to a user via an output device 2140and/or for controlling a function or operation of the generator 1100.Additionally, any type of information may be communicated to first datacircuit 2060 for storage therein via the first data circuit interface2040 (e.g., using the programmable logic device 2000). Such informationmay comprise, for example, an updated number of operations in which thesurgical device has been used and/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., instrument 1106 may be detachable from handpiece 1107)to promote instrument interchangeability and/or disposability. In suchcases, known generators may be limited in their ability to recognizeparticular instrument configurations being used and to optimize controland diagnostic processes accordingly. The addition of readable datacircuits to surgical device instruments to address this issue isproblematic from a compatibility standpoint, however. For example, itmay be impractical to design a surgical device to maintain backwardcompatibility with generators that lack the requisite data readingfunctionality due to, for example, differing signal schemes, designcomplexity and cost. Other aspects of instruments address these concernsby using data circuits that may be implemented in existing surgicalinstruments economically and with minimal design changes to preservecompatibility of the surgical devices with current generator platforms.

Additionally, aspects of the generator 1100 may enable communicationwith instrument-based data circuits. For example, the generator 1100 maybe configured to communicate with a second data circuit (e.g., a datacircuit) contained in an instrument (e.g., instrument 1104, 1106 or1108) of a surgical device. The instrument interface circuit 1980 maycomprise a second data circuit interface 2100 to enable thiscommunication. In one aspect, the second data circuit interface 2100 maycomprise a tri-state digital interface, although other interfaces mayalso be used. In certain aspects, the second data circuit may generallybe any circuit for transmitting and/or receiving data. In one aspect,for example, the second data circuit may store information pertaining tothe particular surgical instrument with which it is associated. Suchinformation may include, for example, a model number, a serial number, anumber of operations in which the surgical instrument has been used,and/or any other type of information. Additionally or alternatively, anytype of information may be communicated to the second data circuit forstorage therein via the second data circuit interface 2100 (e.g., usingthe programmable logic device 2000). Such information may comprise, forexample, an updated number of operations in which the instrument hasbeen used and/or dates and/or times of its usage. In certain aspects,the second data circuit may transmit data acquired by one or moresensors (e.g., an instrument-based temperature sensor). In certainaspects, the second data circuit may receive data from the generator1100 and provide an indication to a user (e.g., an LED indication orother visible indication) based on the received data.

In certain aspects, the second data circuit and the second data circuitinterface 2100 may be configured such that communication between theprogrammable logic device 2000 and the second data circuit can beeffected without the need to provide additional conductors for thispurpose (e.g., dedicated conductors of a cable connecting a handpiece tothe generator 1100). In one aspect, for example, information may becommunicated to and from the second data circuit using a one-wire buscommunication scheme implemented on existing cabling, such as one of theconductors used transmit interrogation signals from the signalconditioning circuit 2020 to a control circuit in a handpiece. In thisway, design changes or modifications to the surgical device that mightotherwise be necessary are minimized or reduced. Moreover, becausedifferent types of communications can be implemented over a commonphysical channel (either with or without frequency-band separation), thepresence of a second data circuit may be “invisible” to generators thatdo not have the requisite data reading functionality, thus enablingbackward compatibility of the surgical device instrument.

In certain aspects, the isolated stage 1520 may comprise at least oneblocking capacitor 2960-1 (FIG. 25C) connected to the drive signaloutput 1600 b to prevent passage of DC current to a patient. A singleblocking capacitor may be required to comply with medical regulations orstandards, for example. While failure in single-capacitor designs isrelatively uncommon, such failure may nonetheless have negativeconsequences. In one aspect, a second blocking capacitor 2960-2 may beprovided in series with the blocking capacitor 2960-1, with currentleakage from a point between the blocking capacitors 2960-1, 2960-2being monitored by, for example, an ADC 2980 for sampling a voltageinduced by leakage current. The samples may be received by theprogrammable logic device 2000, for example. Based on changes in theleakage current (as indicated by the voltage samples in the aspect ofFIG. 24), the generator 1100 may determine when at least one of theblocking capacitors 2960-1, 2960-2 has failed. Accordingly, the aspectof FIG. 24 may provide a benefit over single-capacitor designs having asingle point of failure.

In certain aspects, the non-isolated stage 1540 may comprise a powersupply 2110 for outputting DC power at a suitable voltage and current.The power supply may comprise, for example, a 400 W power supply foroutputting a 48 VDC system voltage. As discussed above, the power supply2110 may further comprise one or more DC/DC voltage converters 2130 forreceiving the output of the power supply to generate DC outputs at thevoltages and currents required by the various components of thegenerator 1100. As discussed above in connection with the controller1960, one or more of the DC/DC voltage converters 2130 may receive aninput from the controller 1960 when activation of the “on/off” inputdevice 2150 by a user is detected by the controller 1960 to enableoperation of, or wake, the DC/DC voltage converters 2130.

FIGS. 26A-26B illustrate certain functional and structural aspects ofone aspect of the generator 1100. Feedback indicating current andvoltage output from the secondary winding 1580 of the power transformer1560 is received by the ADCs 1780, 1800, respectively. As shown, theADCs 1780, 1800 may be implemented as a 2-channel ADC and may sample thefeedback signals at a high speed (e.g., 80 Msps) to enable oversampling(e.g., approximately 200× oversampling) of the drive signals. Thecurrent and voltage feedback signals may be suitably conditioned in theanalog domain (e.g., amplified, filtered) prior to processing by theADCs 1780, 1800. Current and voltage feedback samples from the ADCs1780, 1800 may be individually buffered and subsequently multiplexed orinterleaved into a single data stream within block 2120 of theprogrammable logic device 1660. In the aspect of FIGS. 26A-26B, theprogrammable logic device 1660 comprises an FPGA.

The multiplexed current and voltage feedback samples may be received bya parallel data acquisition port (PDAP) implemented within block 2144 ofthe processor 1740. The PDAP may comprise a packing unit forimplementing any of a number of methodologies for correlating themultiplexed feedback samples with a memory address. In one aspect, forexample, feedback samples corresponding to a particular LUT sampleoutput by the programmable logic device 1660 may be stored at one ormore memory addresses that are correlated or indexed with the LUTaddress of the LUT sample. In another aspect, feedback samplescorresponding to a particular LUT sample output by the programmablelogic device 1660 may be stored, along with the LUT address of the LUTsample, at a common memory location. In any event, the feedback samplesmay be stored such that the address of the LUT sample from which aparticular set of feedback samples originated may be subsequentlyascertained. As discussed above, synchronization of the LUT sampleaddresses and the feedback samples in this way contributes to thecorrect timing and stability of the pre-distortion algorithm. A directmemory access (DMA) controller implemented at block 2166 of theprocessor 1740 may store the feedback samples (and any LUT sampleaddress data, where applicable) at a designated memory location 2180 ofthe processor 1740 (e.g., internal RAM).

Block 2200 of the processor 1740 may implement a pre-distortionalgorithm for pre-distorting or modifying the LUT samples stored in theprogrammable logic device 1660 on a dynamic, ongoing basis. As discussedabove, pre-distortion of the LUT samples may compensate for varioussources of distortion present in the output drive circuit of thegenerator 1100. The pre-distorted LUT samples, when processed throughthe drive circuit, will therefore result in a drive signal having thedesired waveform shape (e.g., sinusoidal) for optimally driving theultrasonic transducer.

At block 2220 of the pre-distortion algorithm, the current through themotional branch of the ultrasonic transducer is determined. The motionalbranch current may be determined using Kirchhoff's Current Law based on,for example, the current and voltage feedback samples stored at memorylocation 2180 (which, when suitably scaled, may be representative ofI_(g) and V_(g) in the model of FIG. 23 discussed above), a value of theultrasonic transducer static capacitance C₀ (measured or known a priori)and a known value of the drive frequency. A motional branch currentsample for each set of stored current and voltage feedback samplesassociated with a LUT sample may be determined.

At block 2240 of the pre-distortion algorithm, each motional branchcurrent sample determined at block 2220 is compared to a sample of adesired current waveform shape to determine a difference, or sampleamplitude error, between the compared samples. For this determination,the sample of the desired current waveform shape may be supplied, forexample, from a waveform shape LUT 2260 containing amplitude samples forone cycle of a desired current waveform shape. The particular sample ofthe desired current waveform shape from the LUT 2260 used for thecomparison may be dictated by the LUT sample address associated with themotional branch current sample used in the comparison. Accordingly, theinput of the motional branch current to block 2240 may be synchronizedwith the input of its associated LUT sample address to block 2240. TheLUT samples stored in the programmable logic device 1660 and the LUTsamples stored in the waveform shape LUT 2260 may therefore be equal innumber. In certain aspects, the desired current waveform shaperepresented by the LUT samples stored in the waveform shape LUT 2260 maybe a fundamental sine wave. Other waveform shapes may be desirable. Forexample, it is contemplated that a fundamental sine wave for drivingmain longitudinal motion of an ultrasonic transducer superimposed withone or more other drive signals at other frequencies, such as a thirdorder harmonic for driving at least two mechanical resonances forbeneficial vibrations of transverse or other modes, could be used.

Each value of the sample amplitude error determined at block 2240 may betransmitted to the LUT of the programmable logic device 1660 (shown atblock 2280 in FIG. 26A) along with an indication of its associated LUTaddress. Based on the value of the sample amplitude error and itsassociated address (and, optionally, values of sample amplitude errorfor the same LUT address previously received), the LUT 2280 (or othercontrol block of the programmable logic device 1660) may pre-distort ormodify the value of the LUT sample stored at the LUT address such thatthe sample amplitude error is reduced or minimized. It will beappreciated that such pre-distortion or modification of each LUT samplein an iterative manner across the entire range of LUT addresses willcause the waveform shape of the generator's output current to match orconform to the desired current waveform shape represented by the samplesof the waveform shape LUT 2260.

Current and voltage amplitude measurements, power measurements andimpedance measurements may be determined at block 2300 of the processor1740 based on the current and voltage feedback samples stored at memorylocation 2180. Prior to the determination of these quantities, thefeedback samples may be suitably scaled and, in certain aspects,processed through a suitable filter 2320 to remove noise resulting from,for example, the data acquisition process and induced harmoniccomponents. The filtered voltage and current samples may thereforesubstantially represent the fundamental frequency of the generator'sdrive output signal. In certain aspects, the filter 2320 may be a finiteimpulse response (FIR) filter applied in the frequency domain. Suchaspects may use the Fast Fourier Transform (FFT) of the output drivesignal current and voltage signals. In certain aspects, the resultingfrequency spectrum may be used to provide additional generatorfunctionality. In one aspect, for example, the ratio of the secondand/or third order harmonic component relative to the fundamentalfrequency component may be used as a diagnostic indicator.

At block 2340 (FIG. 26B), a root mean square (RMS) calculation may beapplied to a sample size of the current feedback samples representing anintegral number of cycles of the drive signal to generate a measurementI_(rms) representing the drive signal output current.

At block 2360, a root mean square (RMS) calculation may be applied to asample size of the voltage feedback samples representing an integralnumber of cycles of the drive signal to determine a measurement V_(rms)representing the drive signal output voltage.

At block 2380, the current and voltage feedback samples may bemultiplied point by point, and a mean calculation is applied to samplesrepresenting an integral number of cycles of the drive signal todetermine a measurement P_(r) of the generator's real output power.

At block 2400, measurement P_(a) of the generator's apparent outputpower may be determined as the product V_(rms)·I_(rms).

At block 2420, measurement Z_(m) of the load impedance magnitude may bedetermined as the quotient V_(rms)/I_(rms).

In certain aspects, the quantities I_(rms), V_(rms), P_(r), P_(a) andZ_(m) determined at blocks 2340, 2360, 2380, 2400 and 2420 may be usedby the generator 1100 to implement any of a number of control and/ordiagnostic processes. In certain aspects, any of these quantities may becommunicated to a user via, for example, an output device 2140 integralwith the generator 1100 or an output device 2140 connected to thegenerator 1100 through a suitable communication interface (e.g., a USBinterface). Various diagnostic processes may include, withoutlimitation, handpiece integrity, instrument integrity, instrumentattachment integrity, instrument overload, approaching instrumentoverload, frequency lock failure, over-voltage condition, over-currentcondition, over-power condition, voltage sense failure, current sensefailure, audio indication failure, visual indication failure, shortcircuit condition, power delivery failure, or blocking capacitorfailure, for example.

Block 2440 of the processor 1740 may implement a phase control algorithmfor determining and controlling the impedance phase of an electricalload (e.g., the ultrasonic transducer) driven by the generator 1100. Asdiscussed above, by controlling the frequency of the drive signal tominimize or reduce the difference between the determined impedance phaseand an impedance phase setpoint (e.g., 0°), the effects of harmonicdistortion may be minimized or reduced, and the accuracy of the phasemeasurement increased.

The phase control algorithm receives as input the current and voltagefeedback samples stored in the memory location 2180. Prior to their usein the phase control algorithm, the feedback samples may be suitablyscaled and, in certain aspects, processed through a suitable filter 2460(which may be identical to filter 2320) to remove noise resulting fromthe data acquisition process and induced harmonic components, forexample. The filtered voltage and current samples may thereforesubstantially represent the fundamental frequency of the generator'sdrive output signal.

At block 2480 of the phase control algorithm, the current through themotional branch of the ultrasonic transducer is determined. Thisdetermination may be identical to that described above in connectionwith block 2220 of the pre-distortion algorithm. The output of block2480 may thus be, for each set of stored current and voltage feedbacksamples associated with a LUT sample, a motional branch current sample.

At block 2500 of the phase control algorithm, impedance phase isdetermined based on the synchronized input of motional branch currentsamples determined at block 2480 and corresponding voltage feedbacksamples. In certain aspects, the impedance phase is determined as theaverage of the impedance phase measured at the rising edge of thewaveforms and the impedance phase measured at the falling edge of thewaveforms.

At block 2520 of the of the phase control algorithm, the value of theimpedance phase determined at block 2220 is compared to phase setpoint2540 to determine a difference, or phase error, between the comparedvalues.

At block 2560 (FIG. 26A) of the phase control algorithm, based on avalue of phase error determined at block 2520 and the impedancemagnitude determined at block 2420, a frequency output for controllingthe frequency of the drive signal is determined. The value of thefrequency output may be continuously adjusted by the block 2560 andtransferred to a DDS control block 2680 (discussed below) in order tomaintain the impedance phase determined at block 2500 at the phasesetpoint (e.g., zero phase error). In certain aspects, the impedancephase may be regulated to a 0° phase setpoint. In this way, any harmonicdistortion will be centered about the crest of the voltage waveform,enhancing the accuracy of phase impedance determination.

Block 2580 of the processor 1740 may implement an algorithm formodulating the current amplitude of the drive signal in order to controlthe drive signal current, voltage and power in accordance with userspecified setpoints, or in accordance with requirements specified byother processes or algorithms implemented by the generator 1100. Controlof these quantities may be realized, for example, by scaling the LUTsamples in the LUT 2280 and/or by adjusting the full-scale outputvoltage of the DAC 1680 (which supplies the input to the power amplifier1620) via a DAC 1860. Block 2600 (which may be implemented as a PIDcontroller in certain aspects) may receive, as input, current feedbacksamples (which may be suitably scaled and filtered) from the memorylocation 2180. The current feedback samples may be compared to a“current demand” I_(d) value dictated by the controlled variable (e.g.,current, voltage or power) to determine if the drive signal is supplyingthe necessary current. In aspects in which drive signal current is thecontrol variable, the current demand I_(d) may be specified directly bya current setpoint 2620A (I_(sp)). For example, an RMS value of thecurrent feedback data (determined as in block 2340) may be compared touser-specified RMS current setpoint I_(sp) to determine the appropriatecontroller action. If, for example, the current feedback data indicatesan RMS value less than the current setpoint I_(sp), LUT scaling and/orthe full-scale output voltage of the DAC 1680 may be adjusted by theblock 2600 such that the drive signal current is increased. Conversely,block 2600 may adjust LUT scaling and/or the full-scale output voltageof the DAC 1680 to decrease the drive signal current when the currentfeedback data indicates an RMS value greater than the current setpointI_(sp).

In aspects in which the drive signal voltage is the control variable,the current demand I_(d) may be specified indirectly, for example, basedon the current required to maintain a desired voltage setpoint 2620B(V_(sp)) given the load impedance magnitude Z_(m) measured at block 2420(e.g. I_(d)=V_(sp)/Z_(m)). Similarly, in aspects in which drive signalpower is the control variable, the current demand I_(d) may be specifiedindirectly, for example, based on the current required to maintain adesired power setpoint 2620C (P_(sp)) given the voltage V_(rms) measuredat blocks 2360 (e.g. I_(d)=P_(sp)/V_(rms)).

Block 2680 (FIG. 26A) may implement a DDS control algorithm forcontrolling the drive signal by recalling LUT samples stored in the LUT2280. In certain aspects, the DDS control algorithm may be anumerically-controlled oscillator (NCO) algorithm for generating samplesof a waveform at a fixed clock rate using a point (memorylocation)-skipping technique. The NCO algorithm may implement a phaseaccumulator, or frequency-to-phase converter, that functions as anaddress pointer for recalling LUT samples from the LUT 2280. In oneaspect, the phase accumulator may be a D step size, modulo N phaseaccumulator, where D is a positive integer representing a frequencycontrol value, and N is the number of LUT samples in the LUT 2280. Afrequency control value of D=1, for example, may cause the phaseaccumulator to sequentially point to every address of the LUT 2280,resulting in a waveform output replicating the waveform stored in theLUT 2280. When D>1, the phase accumulator may skip addresses in the LUT2280, resulting in a waveform output having a higher frequency.Accordingly, the frequency of the waveform generated by the DDS controlalgorithm may therefore be controlled by suitably varying the frequencycontrol value. In certain aspects, the frequency control value may bedetermined based on the output of the phase control algorithmimplemented at block 2440. The output of block 2680 may supply the inputof DAC 1680, which in turn supplies a corresponding analog signal to aninput of the power amplifier 1620.

Block 2700 of the processor 1740 may implement a switch-mode convertercontrol algorithm for dynamically modulating the rail voltage of thepower amplifier 1620 based on the waveform envelope of the signal beingamplified, thereby improving the efficiency of the power amplifier 1620.In certain aspects, characteristics of the waveform envelope may bedetermined by monitoring one or more signals contained in the poweramplifier 1620. In one aspect, for example, characteristics of thewaveform envelope may be determined by monitoring the minima of a drainvoltage (e.g., a MOSFET drain voltage) that is modulated in accordancewith the envelope of the amplified signal. A minima voltage signal maybe generated, for example, by a voltage minima detector coupled to thedrain voltage. The minima voltage signal may be sampled by ADC 1760,with the output minima voltage samples being received at block 2720 ofthe switch-mode converter control algorithm. Based on the values of theminima voltage samples, block 2740 may control a PWM signal output by aPWM generator 2760, which, in turn, controls the rail voltage suppliedto the power amplifier 1620 by the switch-mode regulator 1700. Incertain aspects, as long as the values of the minima voltage samples areless than a minima target 2780 input into block 2720, the rail voltagemay be modulated in accordance with the waveform envelope ascharacterized by the minima voltage samples. When the minima voltagesamples indicate low envelope power levels, for example, block 2740 maycause a low rail voltage to be supplied to the power amplifier 1620,with the full rail voltage being supplied only when the minima voltagesamples indicate maximum envelope power levels. When the minima voltagesamples fall below the minima target 2780, block 2740 may cause the railvoltage to be maintained at a minimum value suitable for ensuring properoperation of the power amplifier 1620.

FIG. 27 is a schematic diagram of one aspect of an electrical circuit2900, suitable for driving an ultrasonic transducer, such as ultrasonictransducer 1120, in accordance with at least one aspect of the presentdisclosure. The electrical circuit 2900 comprises an analog multiplexer2980. The analog multiplexer 2980 multiplexes various signals from theupstream channels SCL-A, SDA-A such as ultrasonic, battery, and powercontrol circuit. A current sensor 2982 is coupled in series with thereturn or ground leg of the power supply circuit to measure the currentsupplied by the power supply. A field effect transistor (FET)temperature sensor 2984 provides the ambient temperature. A pulse widthmodulation (PWM) watchdog timer 2988 automatically generates a systemreset if the main program neglects to periodically service it. It isprovided to automatically reset the electrical circuit 2900 when ithangs or freezes because of a software or hardware fault. It will beappreciated that the electrical circuit 2900 may be configured as an RFdriver circuit for driving the ultrasonic transducer or for driving RFelectrodes such as the electrical circuit 3600 shown in FIG. 32, forexample. Accordingly, with reference now back to FIG. 27, the electricalcircuit 2900 can be used to drive both ultrasonic transducers and RFelectrodes interchangeably. If driven simultaneously, filter circuitsmay be provided in the corresponding first stage circuits 3404 (FIG. 30)to select either the ultrasonic waveform or the RF waveform. Suchfiltering techniques are described in commonly owned U.S. Pat. Pub. No.US-2017-0086910-A1, titled TECHNIQUES FOR CIRCUIT TOPOLOGIES FORCOMBINED GENERATOR, which is herein incorporated by reference in itsentirety.

A drive circuit 2986 provides left and right ultrasonic energy outputs.A digital signal that represents the signal waveform is provided to theSCL-A, SDA-A inputs of the analog multiplexer 2980 from a controlcircuit, such as the control circuit 3200 (FIG. 28). A digital-to-analogconverter 2990 (DAC) converts the digital input to an analog output todrive a PWM circuit 2992 coupled to an oscillator 2994. The PWM circuit2992 provides a first signal to a first gate drive circuit 2996 acoupled to a first transistor output stage 2998 a to drive a firstUltrasonic (LEFT) energy output. The PWM circuit 2992 also provides asecond signal to a second gate drive circuit 2996 b coupled to a secondtransistor output stage 2998 b to drive a second Ultrasonic (RIGHT)energy output. A voltage sensor 2999 is coupled between the UltrasonicLEFT/RIGHT output terminals to measure the output voltage. The drivecircuit 2986, the first and second drive circuits 2996 a, 2996 b, andthe first and second transistor output stages 2998 a, 2998 b define afirst stage amplifier circuit. In operation, the control circuit 3200(FIG. 28) generates a digital waveform 4300 (FIG. 37) employing circuitssuch as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 35 and36). The DAC 2990 receives the digital waveform 4300 and converts itinto an analog waveform, which is received and amplified by the firststage amplifier circuit.

FIG. 28 is a schematic diagram of a control circuit 3200, such ascontrol circuit 3212, in accordance with at least one aspect of thepresent disclosure. The control circuit 3200 is located within a housingof the battery assembly. The battery assembly is the energy source for avariety of local power supplies 3215. The control circuit comprises amain processor 3214 coupled via an interface master 3218 to variousdownstream circuits by way of outputs SCL-A and SDA-A, SCL-B and SDA-B,SCL-C and SDA-C, for example. In one aspect, the interface master 3218is a general purpose serial interface such as an I²C serial interface.The main processor 3214 also is configured to drive switches 3224through general purposes input/output (GPIO) 3220, a display 3226 (e.g.,and LCD display), and various indicators 3228 through GPIO 3222. Awatchdog processor 3216 is provided to control the main processor 3214.A switch 3230 is provided in series with a battery 3211 to activate thecontrol circuit 3212 upon insertion of the battery assembly into ahandle assembly of a surgical instrument.

In one aspect, the main processor 3214 is coupled to the electricalcircuit 2900 (FIG. 27) by way of output terminals SCL-A, SDA-A. The mainprocessor 3214 comprises a memory for storing tables of digitized drivesignals or waveforms that are transmitted to the electrical circuit 2900for driving the ultrasonic transducer 1120, for example. In otheraspects, the main processor 3214 may generate a digital waveform andtransmit it to the electrical circuit 2900 or may store the digitalwaveform for later transmission to the electrical circuit 2900. The mainprocessor 3214 also may provide RF drive by way of output terminalsSCL-B, SDA-B and various sensors (e.g., Hall-effect sensors,magneto-rheological fluid (MRF) sensors, etc.) by way of outputterminals SCL-C, SDA-C. In one aspect, the main processor 3214 isconfigured to sense the presence of ultrasonic drive circuitry and/or RFdrive circuitry to enable appropriate software and user interfacefunctionality.

In one aspect, the main processor 3214 may be an LM 4F230H5QR, availablefrom Texas Instruments, for example. In at least one example, the TexasInstruments LM4F230H5QR is an ARM Cortex-M4F Processor Core comprisingon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QED analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available from the productdatasheet. Other processors may be readily substituted and, accordingly,the present disclosure should not be limited in this context.

FIG. 29 shows a simplified block circuit diagram illustrating anotherelectrical circuit 3300 contained within a modular ultrasonic surgicalinstrument 3334, in accordance with at least one aspect of the presentdisclosure. The electrical circuit 3300 includes a processor 3302, aclock 3330, a memory 3326, a power supply 3304 (e.g., a battery), aswitch 3306, such as a metal-oxide semiconductor field effect transistor(MOSFET) power switch, a drive circuit 3308 (PLL), a transformer 3310, asignal smoothing circuit 3312 (also referred to as a matching circuitand can be, for example, a tank circuit), a sensing circuit 3314, atransducer 1120, and a shaft assembly (e.g. shaft assembly 1126, 1129)comprising an ultrasonic transmission waveguide that terminates at anultrasonic blade (e.g. ultrasonic blade 1128, 1149) which may bereferred to herein simply as the waveguide.

One feature of the present disclosure that severs dependency on highvoltage (120 VAC) input power (a characteristic of general ultrasoniccutting devices) is the utilization of low-voltage switching throughoutthe wave-forming process and the amplification of the driving signalonly directly before the transformer stage. For this reason, in oneaspect of the present disclosure, power is derived from only a battery,or a group of batteries, small enough to fit either within a handleassembly. State-of-the-art battery technology provides powerfulbatteries of a few centimeters in height and width and a few millimetersin depth. By combining the features of the present disclosure to providea self-contained and self-powered ultrasonic device, a reduction inmanufacturing cost may be achieved.

The output of the power supply 3304 is fed to and powers the processor3302. The processor 3302 receives and outputs signals and, as will bedescribed below, functions according to custom logic or in accordancewith computer programs that are executed by the processor 3302. Asdiscussed above, the electrical circuit 3300 can also include a memory3326, preferably, random access memory (RAM), that storescomputer-readable instructions and data.

The output of the power supply 3304 also is directed to the switch 3306having a duty cycle controlled by the processor 3302. By controlling theon-time for the switch 3306, the processor 3302 is able to dictate thetotal amount of power that is ultimately delivered to the transducer1120. In one aspect, the switch 3306 is a MOSFET, although otherswitches and switching configurations are adaptable as well. The outputof the switch 3306 is fed to a drive circuit 3308 that contains, forexample, a phase detecting phase-locked loop (PLL) and/or a low-passfilter and/or a voltage-controlled oscillator. The output of the switch3306 is sampled by the processor 3302 to determine the voltage andcurrent of the output signal (V_(IN) and I_(IN), respectively). Thesevalues are used in a feedback architecture to adjust the pulse widthmodulation of the switch 3306. For instance, the duty cycle of theswitch 3306 can vary from about 20% to about 80%, depending on thedesired and actual output from the switch 3306.

The drive circuit 3308, which receives the signal from the switch 3306,includes an oscillatory circuit that turns the output of the switch 3306into an electrical signal having an ultrasonic frequency, e.g., 55 kHz(VCO). As explained above, a smoothed-out version of this ultrasonicwaveform is ultimately fed to the ultrasonic transducer 1120 to producea resonant sine wave along an ultrasonic transmission waveguide.

At the output of the drive circuit 3308 is a transformer 3310 that isable to step up the low voltage signal(s) to a higher voltage. It isnoted that upstream switching, prior to the transformer 3310, isperformed at low (e.g., battery driven) voltages, something that, todate, has not been possible for ultrasonic cutting and cautery devices.This is at least partially due to the fact that the deviceadvantageously uses low on-resistance MOSFET switching devices. Lowon-resistance MOSFET switches are advantageous, as they produce lowerswitching losses and less heat than a traditional MOSFET device andallow higher current to pass through. Therefore, the switching stage(pre-transformer) can be characterized as low voltage/high current. Toensure the lower on-resistance of the amplifier MOSFET(s), the MOSFET(s)are run, for example, at 10 V. In such a case, a separate 10 VDC powersupply can be used to feed the MOSFET gate, which ensures that theMOSFET is fully on and a reasonably low on resistance is achieved. Inone aspect of the present disclosure, the transformer 3310 steps up thebattery voltage to 120 V root-mean-square (RMS). Transformers are knownin the art and are, therefore, not explained here in detail.

In the circuit configurations described, circuit component degradationcan negatively impact the circuit performance of the circuit. One factorthat directly affects component performance is heat. Known circuitsgenerally monitor switching temperatures (e.g., MOSFET temperatures).However, because of the technological advancements in MOSFET designs,and the corresponding reduction in size, MOSFET temperatures are nolonger a valid indicator of circuit loads and heat. For this reason, inaccordance with at least one aspect of the present disclosure, thesensing circuit 3314 senses the temperature of the transformer 3310.This temperature sensing is advantageous as the transformer 3310 is runat or very close to its maximum temperature during use of the device.Additional temperature will cause the core material, e.g., the ferrite,to break down and permanent damage can occur. The present disclosure canrespond to a maximum temperature of the transformer 3310 by, forexample, reducing the driving power in the transformer 3310, signalingthe user, turning the power off, pulsing the power, or other appropriateresponses.

In one aspect of the present disclosure, the processor 3302 iscommunicatively coupled to the end effector (e.g. 1122, 1125), which isused to place material in physical contact with the ultrasonic blade(e.g. 1128, 1149). Sensors are provided that measure, at the endeffector, a clamping force value (existing within a known range) and,based upon the received clamping force value, the processor 3302 variesthe motional voltage V_(M). Because high force values combined with aset motional rate can result in high blade temperatures, a temperaturesensor 3332 can be communicatively coupled to the processor 3302, wherethe processor 3302 is operable to receive and interpret a signalindicating a current temperature of the blade from the temperaturesensor 3336 and to determine a target frequency of blade movement basedupon the received temperature. In another aspect, force sensors such asstrain gages or pressure sensors may be coupled to the trigger (e.g.1143, 1147) to measure the force applied to the trigger by the user. Inanother aspect, force sensors such as strain gages or pressure sensorsmay be coupled to a switch button such that displacement intensitycorresponds to the force applied by the user to the switch button.

In accordance with at least one aspect of the present disclosure, thePLL portion of the drive circuit 3308, which is coupled to the processor3302, is able to determine a frequency of waveguide movement andcommunicate that frequency to the processor 3302. The processor 3302stores this frequency value in the memory 3326 when the device is turnedoff. By reading the clock 3330, the processor 3302 is able to determinean elapsed time after the device is shut off and retrieve the lastfrequency of waveguide movement if the elapsed time is less than apredetermined value. The device can then start up at the last frequency,which, presumably, is the optimum frequency for the current load.

Modular Battery Powered Handheld Surgical Instrument with MultistageGenerator Circuits

In another aspect, the present disclosure provides a modular batterypowered handheld surgical instrument with multistage generator circuits.Disclosed is a surgical instrument that includes a battery assembly, ahandle assembly, and a shaft assembly where the battery assembly and theshaft assembly are configured to mechanically and electrically connectto the handle assembly. The battery assembly includes a control circuitconfigured to generate a digital waveform. The handle assembly includesa first stage circuit configured to receive the digital waveform,convert the digital waveform into an analog waveform, and amplify theanalog waveform. The shaft assembly includes a second stage circuitcoupled to the first stage circuit to receive, amplify, and apply theanalog waveform to a load.

In one aspect, the present disclosure provides a surgical instrument,comprising: a battery assembly, comprising a control circuit comprisinga battery, a memory coupled to the battery, and a processor coupled tothe memory and the battery, wherein the processor is configured togenerate a digital waveform; a handle assembly comprising a first stagecircuit coupled to the processor, the first stage circuit comprising adigital-to-analog (DAC) converter and a first stage amplifier circuit,wherein the DAC is configured to receive the digital waveform andconvert the digital waveform into an analog waveform, wherein the firststage amplifier circuit is configured to receive and amplify the analogwaveform; and a shaft assembly comprising a second stage circuit coupledto the first stage amplifier circuit to receive the analog waveform,amplify the analog waveform, and apply the analog waveform to a load;wherein the battery assembly and the shaft assembly are configured tomechanically and electrically connect to the handle assembly.

The load may comprise any one of an ultrasonic transducer, an electrode,or a sensor, or any combinations thereof. The first stage circuit maycomprise a first stage ultrasonic drive circuit and a first stagehigh-frequency current drive circuit. The control circuit may beconfigured to drive the first stage ultrasonic drive circuit and thefirst stage high-frequency current drive circuit independently orsimultaneously. The first stage ultrasonic drive circuit may beconfigured to couple to a second stage ultrasonic drive circuit. Thesecond stage ultrasonic drive circuit may be configured to couple to anultrasonic transducer. The first stage high-frequency current drivecircuit may be configured to couple to a second stage high-frequencydrive circuit. The second stage high-frequency drive circuit may beconfigured to couple to an electrode.

The first stage circuit may comprise a first stage sensor drive circuit.The first stage sensor drive circuit may be configured to a second stagesensor drive circuit. The second stage sensor drive circuit may beconfigured to couple to a sensor.

In another aspect, the present disclosure provides a surgicalinstrument, comprising: a battery assembly, comprising a control circuitcomprising a battery, a memory coupled to the battery, and a processorcoupled to the memory and the battery, wherein the processor isconfigured to generate a digital waveform; a handle assembly comprisinga common first stage circuit coupled to the processor, the common firststage circuit comprising a digital-to-analog (DAC) converter and acommon first stage amplifier circuit, wherein the DAC is configured toreceive the digital waveform and convert the digital waveform into ananalog waveform, wherein the common first stage amplifier circuit isconfigured to receive and amplify the analog waveform; and a shaftassembly comprising a second stage circuit coupled to the common firststage amplifier circuit to receive the analog waveform, amplify theanalog waveform, and apply the analog waveform to a load; wherein thebattery assembly and the shaft assembly are configured to mechanicallyand electrically connect to the handle assembly.

The load may comprise any one of an ultrasonic transducer, an electrode,or a sensor, or any combinations thereof. The common first stage circuitmay be configured to drive ultrasonic, high-frequency current, or sensorcircuits. The common first stage drive circuit may be configured tocouple to a second stage ultrasonic drive circuit, a second stagehigh-frequency drive circuit, or a second stage sensor drive circuit.The second stage ultrasonic drive circuit may be configured to couple toan ultrasonic transducer, the second stage high-frequency drive circuitis configured to couple to an electrode, and the second stage sensordrive circuit is configured to couple to a sensor.

In another aspect, the present disclosure provides a surgicalinstrument, comprising a control circuit comprising a memory coupled toa processor, wherein the processor is configured to generate a digitalwaveform; a handle assembly comprising a common first stage circuitcoupled to the processor, the common first stage circuit configured toreceive the digital waveform, convert the digital waveform into ananalog waveform, and amplify the analog waveform; and a shaft assemblycomprising a second stage circuit coupled to the common first stagecircuit to receive and amplify the analog waveform; wherein the shaftassembly is configured to mechanically and electrically connect to thehandle assembly.

The common first stage circuit may be configured to drive ultrasonic,high-frequency current, or sensor circuits. The common first stage drivecircuit may be configured to couple to a second stage ultrasonic drivecircuit, a second stage high-frequency drive circuit, or a second stagesensor drive circuit. The second stage ultrasonic drive circuit may beconfigured to couple to an ultrasonic transducer, the second stagehigh-frequency drive circuit is configured to couple to an electrode,and the second stage sensor drive circuit is configured to couple to asensor.

FIG. 30 illustrates a generator circuit 3400 partitioned into a firststage circuit 3404 and a second stage circuit 3406, in accordance withat least one aspect of the present disclosure. In one aspect, thesurgical instruments of surgical system 1000 described herein maycomprise a generator circuit 3400 partitioned into multiple stages. Forexample, surgical instruments of surgical system 1000 may comprise thegenerator circuit 3400 partitioned into at least two circuits: the firststage circuit 3404 and the second stage circuit 3406 of amplificationenabling operation of RF energy only, ultrasonic energy only, and/or acombination of RF energy and ultrasonic energy. A combination modularshaft assembly 3414 may be powered by the common first stage circuit3404 located within a handle assembly 3412 and the modular second stagecircuit 3406 integral to the modular shaft assembly 3414. As previouslydiscussed throughout this description in connection with the surgicalinstruments of surgical system 1000, a battery assembly 3410 and theshaft assembly 3414 are configured to mechanically and electricallyconnect to the handle assembly 3412. The end effector assembly isconfigured to mechanically and electrically connect the shaft assembly3414.

Turning now to FIG. 30, the generator circuit 3400 is partitioned intomultiple stages located in multiple modular assemblies of a surgicalinstrument, such as the surgical instruments of surgical system 1000described herein. In one aspect, a control stage circuit 3402 may belocated in the battery assembly 3410 of the surgical instrument. Thecontrol stage circuit 3402 is a control circuit 3200 as described inconnection with FIG. 28. The control circuit 3200 comprises a processor3214, which includes internal memory 3217 (FIG. 30) (e.g., volatile andnon-volatile memory), and is electrically coupled to a battery 3211. Thebattery 3211 supplies power to the first stage circuit 3404, the secondstage circuit 3406, and a third stage circuit 3408, respectively. Aspreviously discussed, the control circuit 3200 generates a digitalwaveform 4300 (FIG. 37) using circuits and techniques described inconnection with FIGS. 35 and 36. Returning to FIG. 30, the digitalwaveform 4300 may be configured to drive an ultrasonic transducer,high-frequency (e.g., RF) electrodes, or a combination thereof eitherindependently or simultaneously. If driven simultaneously, filtercircuits may be provided in the corresponding first stage circuits 3404to select either the ultrasonic waveform or the RF waveform. Suchfiltering techniques are described in commonly owned U.S. Pat. Pub. No.US-2017-0086910-A1, titled TECHNIQUES FOR CIRCUIT TOPOLOGIES FORCOMBINED GENERATOR, which is herein incorporated by reference in itsentirety.

The first stage circuits 3404 (e.g., the first stage ultrasonic drivecircuit 3420, the first stage RF drive circuit 3422, and the first stagesensor drive circuit 3424) are located in a handle assembly 3412 of thesurgical instrument. The control circuit 3200 provides the ultrasonicdrive signal to the first stage ultrasonic drive circuit 3420 viaoutputs SCL-A, SDA-A of the control circuit 3200. The first stageultrasonic drive circuit 3420 is described in detail in connection withFIG. 27. The control circuit 3200 provides the RF drive signal to thefirst stage RF drive circuit 3422 via outputs SCL-B, SDA-B of thecontrol circuit 3200. The first stage RF drive circuit 3422 is describedin detail in connection with FIG. 32. The control circuit 3200 providesthe sensor drive signal to the first stage sensor drive circuit 3424 viaoutputs SCL-C, SDA-C of the control circuit 3200. Generally, each of thefirst stage circuits 3404 includes a digital-to-analog (DAC) converterand a first stage amplifier section to drive the second stage circuits3406. The outputs of the first stage circuits 3404 are provided to theinputs of the second stage circuits 3406.

The control circuit 3200 is configured to detect which modules areplugged into the control circuit 3200. For example, the control circuit3200 is configured to detect whether the first stage ultrasonic drivecircuit 3420, the first stage RF drive circuit 3422, or the first stagesensor drive circuit 3424 located in the handle assembly 3412 isconnected to the battery assembly 3410. Likewise, each of the firststage circuits 3404 can detect which second stage circuits 3406 areconnected thereto and that information is provided back to the controlcircuit 3200 to determine the type of signal waveform to generate.Similarly, each of the second stage circuits 3406 can detect which thirdstage circuits 3408 or components are connected thereto and thatinformation is provided back to the control circuit 3200 to determinethe type of signal waveform to generate.

In one aspect, the second stage circuits 3406 (e.g., the ultrasonicdrive second stage circuit 3430, the RF drive second stage circuit 3432,and the sensor drive second stage circuit 3434) are located in the shaftassembly 3414 of the surgical instrument. The first stage ultrasonicdrive circuit 3420 provides a signal to the second stage ultrasonicdrive circuit 3430 via outputs US-Left/US-Right. The second stageultrasonic drive circuit 3430 can include, for example, a transformer,filter, amplifier, and/or signal conditioning circuits. The first stagehigh-frequency (RF) current drive circuit 3422 provides a signal to thesecond stage RF drive circuit 3432 via outputs RF-Left/RF-Right. Inaddition to a transformer and blocking capacitors, the second stage RFdrive circuit 3432 also may include filter, amplifier, and signalconditioning circuits. The first stage sensor drive circuit 3424provides a signal to the second stage sensor drive circuit 3434 viaoutputs Sensor-1/Sensor-2. The second stage sensor drive circuit 3434may include filter, amplifier, and signal conditioning circuitsdepending on the type of sensor. The outputs of the second stagecircuits 3406 are provided to the inputs of the third stage circuits3408.

In one aspect, the third stage circuits 3408 (e.g., the ultrasonictransducer 1120, the RF electrodes 3074 a, 3074 b, and the sensors 3440)may be located in various assemblies 3416 of the surgical instruments.In one aspect, the second stage ultrasonic drive circuit 3430 provides adrive signal to the ultrasonic transducer 1120 piezoelectric stack. Inone aspect, the ultrasonic transducer 1120 is located in the ultrasonictransducer assembly of the surgical instrument. In other aspects,however, the ultrasonic transducer 1120 may be located in the handleassembly 3412, the shaft assembly 3414, or the end effector. In oneaspect, the second stage RF drive circuit 3432 provides a drive signalto the RF electrodes 3074 a, 3074 b, which are generally located in theend effector portion of the surgical instrument. In one aspect, thesecond stage sensor drive circuit 3434 provides a drive signal tovarious sensors 3440 located throughout the surgical instrument.

FIG. 31 illustrates a generator circuit 3500 partitioned into multiplestages where a first stage circuit 3504 is common to the second stagecircuit 3506, in accordance with at least one aspect of the presentdisclosure. In one aspect, the surgical instruments of surgical system1000 described herein may comprise generator circuit 3500 partitionedinto multiple stages. For example, the surgical instruments of surgicalsystem 1000 may comprise the generator circuit 3500 partitioned into atleast two circuits: the first stage circuit 3504 and the second stagecircuit 3506 of amplification enabling operation of high-frequency (RF)energy only, ultrasonic energy only, and/or a combination of RF energyand ultrasonic energy. A combination modular shaft assembly 3514 may bepowered by a common first stage circuit 3504 located within the handleassembly 3512 and a modular second stage circuit 3506 integral to themodular shaft assembly 3514. As previously discussed throughout thisdescription in connection with the surgical instruments of surgicalsystem 1000, a battery assembly 3510 and the shaft assembly 3514 areconfigured to mechanically and electrically connect to the handleassembly 3512. The end effector assembly is configured to mechanicallyand electrically connect the shaft assembly 3514.

As shown in the example of FIG. 31, the battery assembly 3510 portion ofthe surgical instrument comprises a first control circuit 3502, whichincludes the control circuit 3200 previously described. The handleassembly 3512, which connects to the battery assembly 3510, comprises acommon first stage drive circuit 3420. As previously discussed, thefirst stage drive circuit 3420 is configured to drive ultrasonic,high-frequency (RF) current, and sensor loads. The output of the commonfirst stage drive circuit 3420 can drive any one of the second stagecircuits 3506 such as the second stage ultrasonic drive circuit 3430,the second stage high-frequency (RF) current drive circuit 3432, and/orthe second stage sensor drive circuit 3434. The common first stage drivecircuit 3420 detects which second stage circuit 3506 is located in theshaft assembly 3514 when the shaft assembly 3514 is connected to thehandle assembly 3512. Upon the shaft assembly 3514 being connected tothe handle assembly 3512, the common first stage drive circuit 3420determines which one of the second stage circuits 3506 (e.g., the secondstage ultrasonic drive circuit 3430, the second stage RF drive circuit3432, and/or the second stage sensor drive circuit 3434) is located inthe shaft assembly 3514. The information is provided to the controlcircuit 3200 located in the handle assembly 3512 in order to supply asuitable digital waveform 4300 (FIG. 37) to the second stage circuit3506 to drive the appropriate load, e.g., ultrasonic, RF, or sensor. Itwill be appreciated that identification circuits may be included invarious assemblies 3516 in third stage circuit 3508 such as theultrasonic transducer 1120, the electrodes 3074 a, 3074 b, or thesensors 3440. Thus, when a third stage circuit 3508 is connected to asecond stage circuit 3506, the second stage circuit 3506 knows the typeof load that is required based on the identification information.

FIG. 32 is a schematic diagram of one aspect of an electrical circuit3600 configured to drive a high-frequency current (RF), in accordancewith at least one aspect of the present disclosure. The electricalcircuit 3600 comprises an analog multiplexer 3680. The analogmultiplexer 3680 multiplexes various signals from the upstream channelsSCL-A, SDA-A such as RF, battery, and power control circuit. A currentsensor 3682 is coupled in series with the return or ground leg of thepower supply circuit to measure the current supplied by the powersupply. A field effect transistor (FET) temperature sensor 3684 providesthe ambient temperature. A pulse width modulation (PWM) watchdog timer3688 automatically generates a system reset if the main program neglectsto periodically service it. It is provided to automatically reset theelectrical circuit 3600 when it hangs or freezes because of a softwareor hardware fault. It will be appreciated that the electrical circuit3600 may be configured for driving RF electrodes or for driving theultrasonic transducer 1120 as described in connection with FIG. 27, forexample. Accordingly, with reference now back to FIG. 32, the electricalcircuit 3600 can be used to drive both ultrasonic and RF electrodesinterchangeably.

A drive circuit 3686 provides Left and Right RF energy outputs. Adigital signal that represents the signal waveform is provided to theSCL-A, SDA-A inputs of the analog multiplexer 3680 from a controlcircuit, such as the control circuit 3200 (FIG. 28). A digital-to-analogconverter 3690 (DAC) converts the digital input to an analog output todrive a PWM circuit 3692 coupled to an oscillator 3694. The PWM circuit3692 provides a first signal to a first gate drive circuit 3696 acoupled to a first transistor output stage 3698 a to drive a first RF+(Left) energy output. The PWM circuit 3692 also provides a second signalto a second gate drive circuit 3696 b coupled to a second transistoroutput stage 3698 b to drive a second RF− (Right) energy output. Avoltage sensor 3699 is coupled between the RF Left/RF output terminalsto measure the output voltage. The drive circuit 3686, the first andsecond drive circuits 3696 a, 3696 b, and the first and secondtransistor output stages 3698 a, 3698 b define a first stage amplifiercircuit. In operation, the control circuit 3200 (FIG. 28) generates adigital waveform 4300 (FIG. 37) employing circuits such as directdigital synthesis (DDS) circuits 4100, 4200 (FIGS. 35 and 36). The DAC3690 receives the digital waveform 4300 and converts it into an analogwaveform, which is received and amplified by the first stage amplifiercircuit.

Turning now to FIG. 33, there is shown a control circuit 3900 foroperating a battery 3901 powered RF generator circuit 3902 for use witha surgical instrument, in accordance with at least one aspect of thepresent disclosure. The surgical instrument is configured to use bothultrasonic vibration and high-frequency current to carry out surgicalcoagulation/cutting treatments on living tissue, and uses high-frequencycurrent to carry out a surgical coagulation treatment on living tissue.

FIG. 33 illustrates the control circuit 3900 that allows a dualgenerator system to switch between the RF generator circuit 3902 and theultrasonic generator circuit 3920 energy modalities for a surgicalinstrument of the surgical system 1000. In one aspect, a currentthreshold in an RF signal is detected. When the impedance of the tissueis low the high-frequency current through tissue is high when RF energyis used as the treatment source for the tissue. According to one aspect,a visual indicator 3912 or light located on the surgical instrument ofsurgical system 1000 may be configured to be in an on-state during thishigh current period. When the current falls below a threshold, thevisual indicator 3912 is in an off-state. Accordingly, a phototransistor3914 may be configured to detect the transition from an on-state to anoff-state and disengages the RF energy as shown in the control circuit3900 shown in FIG. 33. Therefore, when the energy button is released andan energy switch 3926 is opened, the control circuit 3900 is reset andboth the RF and ultrasonic generator circuits 3902, 3920 are held off.

With reference to FIG. 39, in one aspect, a method of managing an RFgenerator circuit 3902 and ultrasound generator circuit 3920 isprovided. The RF generator circuit 3902 and/or the ultrasound generatorcircuit 3920 may be located in the handle assembly 1109, the ultrasonictransducer/RF generator assembly 1120, the battery assembly, the shaftassembly 1129, and/or the nozzle, of the multifunction electrosurgicalinstrument 1108, for example. The control circuit 3900 is held in areset state if the energy switch 3926 is off (e.g., open). Thus, whenthe energy switch 3926 is opened, the control circuit 3900 is reset andboth the RF and ultrasonic generator circuits 3902, 3920 are turned off.When the energy switch 3926 is squeezed and the energy switch 3926 isengaged (e.g., closed), RF energy is delivered to the tissue and thevisual indicator 3912 operated by a current sensing step-up transformer3904 will be lit while the tissue impedance is low. The light from thevisual indicator 3912 provides a logic signal to keep the ultrasonicgenerator circuit 3920 in the off state. Once the tissue impedanceincreases above a threshold and the high-frequency current through thetissue decreases below a threshold, the visual indicator 3912 turns offand the light transitions to an off-state. A logic signal generated bythis transition turns off a relay 3908, whereby the RF generator circuit3902 is turned off and the ultrasonic generator circuit 3920 is turnedon, to complete the coagulation and cut cycle.

Still with reference to FIG. 39, in one aspect, the dual generatorcircuit configuration employs the on-board RF generator circuit 3902,which is battery 3901 powered, for one modality and a second, on-boardultrasound generator circuit 3920, which may be on-board in the handleassembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or theultrasonic transducer/RF generator assembly 1120 of the multifunctionelectrosurgical instrument 1108, for example. The ultrasonic generatorcircuit 3920 also is battery 3901 operated. In various aspects, the RFgenerator circuit 3902 and the ultrasonic generator circuit 3920 may bean integrated or separable component of the handle assembly 1109.According to various aspects, having the dual RF/ultrasonic generatorcircuits 3902, 3920 as part of the handle assembly 1109 may eliminatethe need for complicated wiring. The RF/ultrasonic generator circuits3902, 3920 may be configured to provide the full capabilities of anexisting generator while utilizing the capabilities of a cordlessgenerator system simultaneously.

Either type of system can have separate controls for the modalities thatare not communicating with each other. The surgeon activates the RF andUltrasonic separately and at their discretion. Another approach would beto provide fully integrated communication schemes that share buttons,tissue status, instrument operating parameters (such as jaw closure,forces, etc.) and algorithms to manage tissue treatment. Variouscombinations of this integration can be implemented to provide theappropriate level of function and performance.

As discussed above, in one aspect, the control circuit 3900 includes thebattery 3901 powered RF generator circuit 3902 comprising a battery asan energy source. As shown, RF generator circuit 3902 is coupled to twoelectrically conductive surfaces referred to herein as electrodes 3906a, 3906 b (i.e., active electrode 3906 a and return electrode 3906 b)and is configured to drive the electrodes 3906 a, 3906 b with RF energy(e.g., high-frequency current). A first winding 3910 a of the step-uptransformer 3904 is connected in series with one pole of the bipolar RFgenerator circuit 3902 and the return electrode 3906 b. In one aspect,the first winding 3910 a and the return electrode 3906 b are connectedto the negative pole of the bipolar RF generator circuit 3902. The otherpole of the bipolar RF generator circuit 3902 is connected to the activeelectrode 3906 a through a switch contact 3909 of the relay 3908, or anysuitable electromagnetic switching device comprising an armature whichis moved by an electromagnet 3936 to operate the switch contact 3909.The switch contact 3909 is closed when the electromagnet 3936 isenergized and the switch contact 3909 is open when the electromagnet3936 is de-energized. When the switch contact is closed, RF currentflows through conductive tissue (not shown) located between theelectrodes 3906 a, 3906 b. It will be appreciated, that in one aspect,the active electrode 3906 a is connected to the positive pole of thebipolar RF generator circuit 3902.

A visual indicator circuit 3905 comprises the step-up transformer 3904,a series resistor R2, and the visual indicator 3912. The visualindicator 3912 can be adapted for use with the surgical instrument 1108and other electrosurgical systems and tools, such as those describedherein. The first winding 3910 a of the step-up transformer 3904 isconnected in series with the return electrode 3906 b and the secondwinding 3910 b of the step-up transformer 3904 is connected in serieswith the resistor R2 and the visual indicator 3912 comprising a typeNE-2 neon bulb, for example.

In operation, when the switch contact 3909 of the relay 3908 is open,the active electrode 3906 a is disconnected from the positive pole ofthe bipolar RF generator circuit 3902 and no current flows through thetissue, the return electrode 3906 b, and the first winding 3910 a of thestep-up transformer 3904. Accordingly, the visual indicator 3912 is notenergized and does not emit light. When the switch contact 3909 of therelay 3908 is closed, the active electrode 3906 a is connected to thepositive pole of the bipolar RF generator circuit 3902 enabling currentto flow through tissue, the return electrode 3906 b, and the firstwinding 3910 a of the step-up transformer 3904 to operate on tissue, forexample cut and cauterize the tissue.

A first current flows through the first winding 3910 a as a function ofthe impedance of the tissue located between the active and returnelectrodes 3906 a, 3906 b providing a first voltage across the firstwinding 3910 a of the step-up transformer 3904. A stepped up secondvoltage is induced across the second winding 3910 b of the step-uptransformer 3904. The secondary voltage appears across the resistor R2and energizes the visual indicator 3912 causing the neon bulb to lightwhen the current through the tissue is greater than a predeterminedthreshold. It will be appreciated that the circuit and component valuesare illustrative and not limited thereto. When the switch contact 3909of the relay 3908 is closed, current flows through the tissue and thevisual indicator 3912 is turned on.

Turning now to the energy switch 3926 portion of the control circuit3900, when the energy switch 3926 is open position, a logic high isapplied to the input of a first inverter 3928 and a logic low is appliedof one of the two inputs of the AND gate 3932. Thus, the output of theAND gate 3932 is low and a transistor 3934 is off to prevent currentfrom flowing through the winding of the electromagnet 3936. With theelectromagnet 3936 in the de-energized state, the switch contact 3909 ofthe relay 3908 remains open and prevents current from flowing throughthe electrodes 3906 a, 3906 b. The logic low output of the firstinverter 3928 also is applied to a second inverter 3930 causing theoutput to go high and resetting a flip-flop 3918 (e.g., a D-Typeflip-flop). At which time, the Q output goes low to turn off theultrasound generator circuit 3920 circuit and the Q output goes high andis applied to the other input of the AND gate 3932.

When the user presses the energy switch 3926 on the instrument handle toapply energy to the tissue between the electrodes 3906 a, 3906 b, theenergy switch 3926 closes and applies a logic low at the input of thefirst inverter 3928, which applies a logic high to other input of theAND gate 3932 causing the output of the AND gate 3932 to go high andturns on the transistor 3934. In the on state, the transistor 3934conducts and sinks current through the winding of the electromagnet 3936to energize the electromagnet 3936 and close the switch contact 3909 ofthe relay 3908. As discussed above, when the switch contact 3909 isclosed, current can flow through the electrodes 3906 a, 3906 b and thefirst winding 3910 a of the step-up transformer 3904 when tissue islocated between the electrodes 3906 a, 3906 b.

As discussed above, the magnitude of the current flowing through theelectrodes 3906 a, 3906 b depends on the impedance of the tissue locatedbetween the electrodes 3906 a, 3906 b. Initially, the tissue impedanceis low and the magnitude of the current high through the tissue and thefirst winding 3910 a. Consequently, the voltage impressed on the secondwinding 3910 b is high enough to turn on the visual indicator 3912. Thelight emitted by the visual indicator 3912 turns on the phototransistor3914, which pulls the input of an inverter 3916 low and causes theoutput of the inverter 3916 to go high. A high input applied to the CLKof the flip-flop 3918 has no effect on the Q or the Q outputs of theflip-flop 3918 and Q output remains low and the Q output remains high.Accordingly, while the visual indicator 3912 remains energized, theultrasound generator circuit 3920 is turned OFF and an ultrasonictransducer 3922 and an ultrasonic blade 3924 of the multifunctionelectrosurgical instrument are not activated.

As the tissue between the electrodes 3906 a, 3906 b dries up, due to theheat generated by the current flowing through the tissue, the impedanceof the tissue increases and the current therethrough decreases. When thecurrent through the first winding 3910 a decreases, the voltage acrossthe second winding 3910 b also decreases and when the voltage dropsbelow a minimum threshold required to operate the visual indicator 3912,the visual indicator 3912 and the phototransistor 3914 turn off. Whenthe phototransistor 3914 turns off, a logic high is applied to the inputof the inverter 3916 and a logic low is applied to the CLK input of theflip-flop 3918 to clock a logic high to the Q output and a logic low tothe Q output. The logic high at the Q output turns on the ultrasoundgenerator circuit 3920 to activate the ultrasonic transducer 3922 andthe ultrasonic blade 3924 to initiate cutting the tissue located betweenthe electrodes 3906 a, 3906 a. Simultaneously or near simultaneouslywith the ultrasound generator circuit 3920 turning on, the Q output ofthe flip-flop 3918 goes low and causes the output of the AND gate 3932to go low and turn off the transistor 3934, thereby de-energizing theelectromagnet 3936 and opening the switch contact 3909 of the relay 3908to cut off the flow of current through the electrodes 3906 a, 3906 b.

While the switch contact 3909 of the relay 3908 is open, no currentflows through the electrodes 3906 a, 3906 b, tissue, and the firstwinding 3910 a of the step-up transformer 3904. Therefore, no voltage isdeveloped across the second winding 3910 b and no current flows throughthe visual indicator 3912.

The state of the Q and the Q outputs of the flip-flop 3918 remain thesame while the user squeezes the energy switch 3926 on the instrumenthandle to maintain the energy switch 3926 closed. Thus, the ultrasonicblade 3924 remains activated and continues cutting the tissue betweenthe jaws of the end effector while no current flows through theelectrodes 3906 a, 3906 b from the bipolar RF generator circuit 3902.When the user releases the energy switch 3926 on the instrument handle,the energy switch 3926 opens and the output of the first inverter 3928goes low and the output of the second inverter 3930 goes high to resetthe flip-flop 3918 causing the Q output to go low and turn off theultrasound generator circuit 3920. At the same time, the Q output goeshigh and the circuit is now in an off state and ready for the user toactuate the energy switch 3926 on the instrument handle to close theenergy switch 3926, apply current to the tissue located between theelectrodes 3906 a, 3906 b, and repeat the cycle of applying RF energy tothe tissue and ultrasonic energy to the tissue as described above.

FIG. 34 illustrates a diagram of a surgical system 4000, whichrepresents one aspect of the surgical system 1000, comprising a feedbacksystem for use with any one of the surgical instruments of surgicalsystem 1000, which may include or implement many of the featuresdescribed herein. The surgical system 4000 may include a generator 4002coupled to a surgical instrument that includes an end effector 4006,which may be activated when a clinician operates a trigger 4010. Invarious aspects, the end effector 4006 may include an ultrasonic bladeto deliver ultrasonic vibration to carry out surgicalcoagulation/cutting treatments on living tissue. In other aspects theend effector 4006 may include electrically conductive elements coupledto an electrosurgical high-frequency current energy source to carry outsurgical coagulation or cauterization treatments on living tissue andeither a mechanical knife with a sharp edge or an ultrasonic blade tocarry out cutting treatments on living tissue. When the trigger 4010 isactuated, a force sensor 4012 may generate a signal indicating theamount of force being applied to the trigger 4010. In addition to, orinstead of a force sensor 4012, the surgical instrument may include aposition sensor 4013, which may generate a signal indicating theposition of the trigger 4010 (e.g., how far the trigger has beendepressed or otherwise actuated). In one aspect, the position sensor4013 may be a sensor positioned with an outer tubular sheath orreciprocating tubular actuating member located within the outer tubularsheath of the surgical instrument. In one aspect, the sensor may be aHall-effect sensor or any suitable transducer that varies its outputvoltage in response to a magnetic field. The Hall-effect sensor may beused for proximity switching, positioning, speed detection, and currentsensing applications. In one aspect, the Hall-effect sensor operates asan analog transducer, directly returning a voltage. With a knownmagnetic field, its distance from the Hall plate can be determined.

A control circuit 4008 may receive the signals from the sensors 4012and/or 4013. The control circuit 4008 may include any suitable analog ordigital circuit components. The control circuit 4008 also maycommunicate with the generator 4002 and/or a transducer 4004 to modulatethe power delivered to the end effector 4006 and/or the generator levelor ultrasonic blade amplitude of the end effector 4006 based on theforce applied to the trigger 4010 and/or the position of the trigger4010 and/or the position of the outer tubular sheath described aboverelative to a reciprocating tubular actuating member located within anouter tubular sheath (e.g., as measured by a Hall-effect sensor andmagnet combination). For example, as more force is applied to thetrigger 4010, more power and/or higher ultrasonic blade amplitude may bedelivered to the end effector 4006. According to various aspects, theforce sensor 4012 may be replaced by a multi-position switch.

According to various aspects, the end effector 4006 may include a clampor clamping mechanism. When the trigger 4010 is initially actuated, theclamping mechanism may close, clamping tissue between a clamp arm andthe end effector 4006. As the force applied to the trigger increases(e.g., as sensed by force sensor 4012) the control circuit 4008 mayincrease the power delivered to the end effector 4006 by the transducer4004 and/or the generator level or ultrasonic blade amplitude broughtabout in the end effector 4006. In one aspect, trigger position, assensed by position sensor 4013 or clamp or clamp arm position, as sensedby position sensor 4013 (e.g., with a Hall-effect sensor), may be usedby the control circuit 4008 to set the power and/or amplitude of the endeffector 4006. For example, as the trigger is moved further towards afully actuated position, or the clamp or clamp arm moves further towardsthe ultrasonic blade (or end effector 4006), the power and/or amplitudeof the end effector 4006 may be increased.

According to various aspects, the surgical instrument of the surgicalsystem 4000 also may include one or more feedback devices for indicatingthe amount of power delivered to the end effector 4006. For example, aspeaker 4014 may emit a signal indicative of the end effector power.According to various aspects, the speaker 4014 may emit a series ofpulse sounds, where the frequency of the sounds indicates power. Inaddition to, or instead of the speaker 4014, the surgical instrument mayinclude a visual display 4016. The visual display 4016 may indicate endeffector power according to any suitable method. For example, the visualdisplay 4016 may include a series of LEDs, where end effector power isindicated by the number of illuminated LEDs. The speaker 4014 and/orvisual display 4016 may be driven by the control circuit 4008. Accordingto various aspects, the surgical instrument may include a ratchetingdevice connected to the trigger 4010. The ratcheting device may generatean audible sound as more force is applied to the trigger 4010, providingan indirect indication of end effector power. The surgical instrumentmay include other features that may enhance safety. For example, thecontrol circuit 4008 may be configured to prevent power from beingdelivered to the end effector 4006 in excess of a predeterminedthreshold. Also, the control circuit 4008 may implement a delay betweenthe time when a change in end effector power is indicated (e.g., byspeaker 4014 or visual display 4016), and the time when the change inend effector power is delivered. In this way, a clinician may have amplewarning that the level of ultrasonic power that is to be delivered tothe end effector 4006 is about to change.

In one aspect, the ultrasonic or high-frequency current generators ofthe surgical system 1000 may be configured to generate the electricalsignal waveform digitally such that the desired using a predeterminednumber of phase points stored in a lookup table to digitize the waveshape. The phase points may be stored in a table defined in a memory, afield programmable gate array (FPGA), or any suitable non-volatilememory. FIG. 35 illustrates one aspect of a fundamental architecture fora digital synthesis circuit such as a direct digital synthesis (DDS)circuit 4100 configured to generate a plurality of wave shapes for theelectrical signal waveform. The generator software and digital controlsmay command the FPGA to scan the addresses in the lookup table 4104which in turn provides varying digital input values to a DAC circuit4108 that feeds a power amplifier. The addresses may be scannedaccording to a frequency of interest. Using such a lookup table 4104enables generating various types of wave shapes that can be fed intotissue or into a transducer, an RF electrode, multiple transducerssimultaneously, multiple RF electrodes simultaneously, or a combinationof RF and ultrasonic instruments. Furthermore, multiple lookup tables4104 that represent multiple wave shapes can be created, stored, andapplied to tissue from a generator.

The waveform signal may be configured to control at least one of anoutput current, an output voltage, or an output power of an ultrasonictransducer and/or an RF electrode, or multiples thereof (e.g. two ormore ultrasonic transducers and/or two or more RF electrodes). Further,where the surgical instrument comprises an ultrasonic components, thewaveform signal may be configured to drive at least two vibration modesof an ultrasonic transducer of the at least one surgical instrument.Accordingly, a generator may be configured to provide a waveform signalto at least one surgical instrument wherein the waveform signalcorresponds to at least one wave shape of a plurality of wave shapes ina table. Further, the waveform signal provided to the two surgicalinstruments may comprise two or more wave shapes. The table may compriseinformation associated with a plurality of wave shapes and the table maybe stored within the generator. In one aspect or example, the table maybe a direct digital synthesis table, which may be stored in an FPGA ofthe generator. The table may be addressed by anyway that is convenientfor categorizing wave shapes. According to one aspect, the table, whichmay be a direct digital synthesis table, is addressed according to afrequency of the waveform signal. Additionally, the informationassociated with the plurality of wave shapes may be stored as digitalinformation in the table.

The analog electrical signal waveform may be configured to control atleast one of an output current, an output voltage, or an output power ofan ultrasonic transducer and/or an RF electrode, or multiples thereof(e.g., two or more ultrasonic transducers and/or two or more RFelectrodes). Further, where the surgical instrument comprises ultrasoniccomponents, the analog electrical signal waveform may be configured todrive at least two vibration modes of an ultrasonic transducer of the atleast one surgical instrument. Accordingly, the generator circuit may beconfigured to provide an analog electrical signal waveform to at leastone surgical instrument wherein the analog electrical signal waveformcorresponds to at least one wave shape of a plurality of wave shapesstored in a lookup table 4104. Further, the analog electrical signalwaveform provided to the two surgical instruments may comprise two ormore wave shapes. The lookup table 4104 may comprise informationassociated with a plurality of wave shapes and the lookup table 4104 maybe stored either within the generator circuit or the surgicalinstrument. In one aspect or example, the lookup table 4104 may be adirect digital synthesis table, which may be stored in an FPGA of thegenerator circuit or the surgical instrument. The lookup table 4104 maybe addressed by anyway that is convenient for categorizing wave shapes.According to one aspect, the lookup table 4104, which may be a directdigital synthesis table, is addressed according to a frequency of thedesired analog electrical signal waveform. Additionally, the informationassociated with the plurality of wave shapes may be stored as digitalinformation in the lookup table 4104.

With the widespread use of digital techniques in instrumentation andcommunications systems, a digitally-controlled method of generatingmultiple frequencies from a reference frequency source has evolved andis referred to as direct digital synthesis. The basic architecture isshown in FIG. 35. In this simplified block diagram, a DDS circuit iscoupled to a processor, controller, or a logic device of the generatorcircuit and to a memory circuit located in the generator circuit of thesurgical system 1000. The DDS circuit 4100 comprises an address counter4102, lookup table 4104, a register 4106, a DAC circuit 4108, and afilter 4112. A stable clock f_(c) is received by the address counter4102 and the register 4106 drives a programmable-read-only-memory (PROM)which stores one or more integral number of cycles of a sinewave (orother arbitrary waveform) in a lookup table 4104. As the address counter4102 steps through memory locations, values stored in the lookup table4104 are written to the register 4106, which is coupled to the DACcircuit 4108. The corresponding digital amplitude of the signal at thememory location of the lookup table 4104 drives the DAC circuit 4108,which in turn generates an analog output signal 4110. The spectralpurity of the analog output signal 4110 is determined primarily by theDAC circuit 4108. The phase noise is basically that of the referenceclock f_(c). The first analog output signal 4110 output from the DACcircuit 4108 is filtered by the filter 4112 and a second analog outputsignal 4114 output by the filter 4112 is provided to an amplifier havingan output coupled to the output of the generator circuit. The secondanalog output signal has a frequency f_(out).

Because the DDS circuit 4100 is a sampled data system, issues involvedin sampling must be considered: quantization noise, aliasing, filtering,etc. For instance, the higher order harmonics of the DAC circuit 4108output frequencies fold back into the Nyquist bandwidth, making themunfilterable, whereas, the higher order harmonics of the output ofphase-locked-loop (PLL) based synthesizers can be filtered. The lookuptable 4104 contains signal data for an integral number of cycles. Thefinal output frequency f_(out) can be changed changing the referenceclock frequency f_(c) or by reprogramming the PROM.

The DDS circuit 4100 may comprise multiple lookup tables 4104 where thelookup table 4104 stores a waveform represented by a predeterminednumber of samples, wherein the samples define a predetermined shape ofthe waveform. Thus multiple waveforms having a unique shape can bestored in multiple lookup tables 4104 to provide different tissuetreatments based on instrument settings or tissue feedback. Examples ofwaveforms include high crest factor RF electrical signal waveforms forsurface tissue coagulation, low crest factor RF electrical signalwaveform for deeper tissue penetration, and electrical signal waveformsthat promote efficient touch-up coagulation. In one aspect, the DDScircuit 4100 can create multiple wave shape lookup tables 4104 andduring a tissue treatment procedure (e.g., “on-the-fly” or in virtualreal time based on user or sensor inputs) switch between different waveshapes stored in separate lookup tables 4104 based on the tissue effectdesired and/or tissue feedback.

Accordingly, switching between wave shapes can be based on tissueimpedance and other factors, for example. In other aspects, the lookuptables 4104 can store electrical signal waveforms shaped to maximize thepower delivered into the tissue per cycle (i.e., trapezoidal or squarewave). In other aspects, the lookup tables 4104 can store wave shapessynchronized in such way that they make maximizing power delivery by themultifunction surgical instrument of surgical system 1000 whiledelivering RF and ultrasonic drive signals. In yet other aspects, thelookup tables 4104 can store electrical signal waveforms to driveultrasonic and RF therapeutic, and/or sub-therapeutic, energysimultaneously while maintaining ultrasonic frequency lock. Custom waveshapes specific to different instruments and their tissue effects can bestored in the non-volatile memory of the generator circuit or in thenon-volatile memory (e.g., EEPROM) of the surgical system 1000 and befetched upon connecting the multifunction surgical instrument to thegenerator circuit. An example of an exponentially damped sinusoid, asused in many high crest factor “coagulation” waveforms is shown in FIG.37.

A more flexible and efficient implementation of the DDS circuit 4100employs a digital circuit called a Numerically Controlled Oscillator(NCO). A block diagram of a more flexible and efficient digitalsynthesis circuit such as a DDS circuit 4200 is shown in FIG. 36. Inthis simplified block diagram, a DDS circuit 4200 is coupled to aprocessor, controller, or a logic device of the generator and to amemory circuit located either in the generator or in any of the surgicalinstruments of surgical system 1000. The DDS circuit 4200 comprises aload register 4202, a parallel delta phase register 4204, an addercircuit 4216, a phase register 4208, a lookup table 4210(phase-to-amplitude converter), a DAC circuit 4212, and a filter 4214.The adder circuit 4216 and the phase register 4208 form part of a phaseaccumulator 4206. A clock frequency f_(c) is applied to the phaseregister 4208 and a DAC circuit 4212. The load register 4202 receives atuning word that specifies output frequency as a fraction of thereference clock frequency signal f_(c). The output of the load register4202 is provided to the parallel delta phase register 4204 with a tuningword M.

The DDS circuit 4200 includes a sample clock that generates the clockfrequency f_(c), the phase accumulator 4206, and the lookup table 4210(e.g., phase to amplitude converter). The content of the phaseaccumulator 4206 is updated once per clock cycle f_(c). When time thephase accumulator 4206 is updated, the digital number, M, stored in theparallel delta phase register 4204 is added to the number in the phaseregister 4208 by the adder circuit 4216. Assuming that the number in theparallel delta phase register 4204 is 00 . . . 01 and that the initialcontents of the phase accumulator 4206 is 00 . . . 00. The phaseaccumulator 4206 is updated by 00 . . . 01 per clock cycle. If the phaseaccumulator 4206 is 32-bits wide, 232 clock cycles (over 4 billion) arerequired before the phase accumulator 4206 returns to 00 . . . 00, andthe cycle repeats.

A truncated output 4218 of the phase accumulator 4206 is provided to aphase-to amplitude converter lookup table 4210 and the output of thelookup table 4210 is coupled to a DAC circuit 4212. The truncated output4218 of the phase accumulator 4206 serves as the address to a sine (orcosine) lookup table. An address in the lookup table corresponds to aphase point on the sinewave from 0° to 360°. The lookup table 4210contains the corresponding digital amplitude information for onecomplete cycle of a sinewave. The lookup table 4210 therefore maps thephase information from the phase accumulator 4206 into a digitalamplitude word, which in turn drives the DAC circuit 4212. The output ofthe DAC circuit is a first analog signal 4220 and is filtered by afilter 4214. The output of the filter 4214 is a second analog signal4222, which is provided to a power amplifier coupled to the output ofthe generator circuit.

In one aspect, the electrical signal waveform may be digitized into 1024(210) phase points, although the wave shape may be digitized is anysuitable number of 2n phase points ranging from 256 (28) to281,474,976,710,656 (248), where n is a positive integer, as shown inTABLE 1. The electrical signal waveform may be expressed asA_(n)(θ_(n)), where a normalized amplitude A_(n) at a point n isrepresented by a phase angle θ_(n) is referred to as a phase point atpoint n. The number of discrete phase points n determines the tuningresolution of the DDS circuit 4200 (as well as the DDS circuit 4100shown in FIG. 35).

TABLE 1 specifies the electrical signal waveform digitized into a numberof phase points.

TABLE 1 N Number of Phase Points 2^(n)  8 256 10 1,024 12 4,096 1416,384 16 65,536 18 262,144 20 1,048,576 22 4,194,304 24 16,777,216 2667,108,864 28 268,435,456 . . . . . . 32 4,294,967,296 . . . . . . 48281,474,976,710,656 . . . . . .

The generator circuit algorithms and digital control circuits scan theaddresses in the lookup table 4210, which in turn provides varyingdigital input values to the DAC circuit 4212 that feeds the filter 4214and the power amplifier. The addresses may be scanned according to afrequency of interest. Using the lookup table enables generating varioustypes of shapes that can be converted into an analog output signal bythe DAC circuit 4212, filtered by the filter 4214, amplified by thepower amplifier coupled to the output of the generator circuit, and fedto the tissue in the form of RF energy or fed to an ultrasonictransducer and applied to the tissue in the form of ultrasonicvibrations which deliver energy to the tissue in the form of heat. Theoutput of the amplifier can be applied to an RF electrode, multiple RFelectrodes simultaneously, an ultrasonic transducer, multiple ultrasonictransducers simultaneously, or a combination of RF and ultrasonictransducers, for example. Furthermore, multiple wave shape tables can becreated, stored, and applied to tissue from a generator circuit.

With reference back to FIG. 35, for n=32, and M=1, the phase accumulator4206 steps through 232 possible outputs before it overflows andrestarts. The corresponding output wave frequency is equal to the inputclock frequency divided by 232. If M=2, then the phase register 1708“rolls over” twice as fast, and the output frequency is doubled. Thiscan be generalized as follows.

For a phase accumulator 4206 configured to accumulate n-bits (ngenerally ranges from 24 to 32 in most DDS systems, but as previouslydiscussed n may be selected from a wide range of options), there are2^(n) possible phase points. The digital word in the delta phaseregister, M, represents the amount the phase accumulator is incrementedper clock cycle. If f_(c) is the clock frequency, then the frequency ofthe output sinewave is equal to:

$f_{0} = \frac{M \cdot f_{c}}{2^{n}}$

The above equation is known as the DDS “tuning equation.” Note that thefrequency resolution of the system is equal to

$\frac{f_{o}}{2^{n}}.$

For n=32, the resolution is greater than one part in four billion. Inone aspect of the DDS circuit 4200, not all of the bits out of the phaseaccumulator 4206 are passed on to the lookup table 4210, but aretruncated, leaving only the first 13 to 15 most significant bits (MSBs),for example. This reduces the size of the lookup table 4210 and does notaffect the frequency resolution. The phase truncation only adds a smallbut acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by a current,voltage, or power at a predetermined frequency. Further, where any oneof the surgical instruments of surgical system 1000 comprises ultrasoniccomponents, the electrical signal waveform may be configured to drive atleast two vibration modes of an ultrasonic transducer of the at leastone surgical instrument. Accordingly, the generator circuit may beconfigured to provide an electrical signal waveform to at least onesurgical instrument wherein the electrical signal waveform ischaracterized by a predetermined wave shape stored in the lookup table4210 (or lookup table 4104 FIG. 35). Further, the electrical signalwaveform may be a combination of two or more wave shapes. The lookuptable 4210 may comprise information associated with a plurality of waveshapes. In one aspect or example, the lookup table 4210 may be generatedby the DDS circuit 4200 and may be referred to as a direct digitalsynthesis table. DDS works by first storing a large repetitive waveformin onboard memory. A cycle of a waveform (sine, triangle, square,arbitrary) can be represented by a predetermined number of phase pointsas shown in TABLE 1 and stored into memory. Once the waveform is storedinto memory, it can be generated at very precise frequencies. The directdigital synthesis table may be stored in a non-volatile memory of thegenerator circuit and/or may be implemented with a FPGA circuit in thegenerator circuit. The lookup table 4210 may be addressed by anysuitable technique that is convenient for categorizing wave shapes.According to one aspect, the lookup table 4210 is addressed according toa frequency of the electrical signal waveform. Additionally, theinformation associated with the plurality of wave shapes may be storedas digital information in a memory or as part of the lookup table 4210.

In one aspect, the generator circuit may be configured to provideelectrical signal waveforms to at least two surgical instrumentssimultaneously. The generator circuit also may be configured to providethe electrical signal waveform, which may be characterized two or morewave shapes, via an output channel of the generator circuit to the twosurgical instruments simultaneously. For example, in one aspect theelectrical signal waveform comprises a first electrical signal to drivean ultrasonic transducer (e.g., ultrasonic drive signal), a second RFdrive signal, and/or a combination thereof. In addition, an electricalsignal waveform may comprise a plurality of ultrasonic drive signals, aplurality of RF drive signals, and/or a combination of a plurality ofultrasonic and RF drive signals.

In addition, a method of operating the generator circuit according tothe present disclosure comprises generating an electrical signalwaveform and providing the generated electrical signal waveform to anyone of the surgical instruments of surgical system 1000, wheregenerating the electrical signal waveform comprises receivinginformation associated with the electrical signal waveform from amemory. The generated electrical signal waveform comprises at least onewave shape. Furthermore, providing the generated electrical signalwaveform to the at least one surgical instrument comprises providing theelectrical signal waveform to at least two surgical instrumentssimultaneously.

The generator circuit as described herein may allow for the generationof various types of direct digital synthesis tables. Examples of waveshapes for RF/Electrosurgery signals suitable for treating a variety oftissue generated by the generator circuit include RF signals with a highcrest factor (which may be used for surface coagulation in RF mode), alow crest factor RF signals (which may be used for deeper tissuepenetration), and waveforms that promote efficient touch-up coagulation.The generator circuit also may generate multiple wave shapes employing adirect digital synthesis lookup table 4210 and, on the fly, can switchbetween particular wave shapes based on the desired tissue effect.Switching may be based on tissue impedance and/or other factors.

In addition to traditional sine/cosine wave shapes, the generatorcircuit may be configured to generate wave shape(s) that maximize thepower into tissue per cycle (i.e., trapezoidal or square wave). Thegenerator circuit may provide wave shape(s) that are synchronized tomaximize the power delivered to the load when driving RF and ultrasonicsignals simultaneously and to maintain ultrasonic frequency lock,provided that the generator circuit includes a circuit topology thatenables simultaneously driving RF and ultrasonic signals. Further,custom wave shapes specific to instruments and their tissue effects canbe stored in a non-volatile memory (NVM) or an instrument EEPROM and canbe fetched upon connecting any one of the surgical instruments ofsurgical system 1000 to the generator circuit.

The DDS circuit 4200 may comprise multiple lookup tables 4104 where thelookup table 4210 stores a waveform represented by a predeterminednumber of phase points (also may be referred to as samples), wherein thephase points define a predetermined shape of the waveform. Thus multiplewaveforms having a unique shape can be stored in multiple lookup tables4210 to provide different tissue treatments based on instrument settingsor tissue feedback. Examples of waveforms include high crest factor RFelectrical signal waveforms for surface tissue coagulation, low crestfactor RF electrical signal waveform for deeper tissue penetration, andelectrical signal waveforms that promote efficient touch-up coagulation.In one aspect, the DDS circuit 4200 can create multiple wave shapelookup tables 4210 and during a tissue treatment procedure (e.g.,“on-the-fly” or in virtual real time based on user or sensor inputs)switch between different wave shapes stored in different lookup tables4210 based on the tissue effect desired and/or tissue feedback.

Accordingly, switching between wave shapes can be based on tissueimpedance and other factors, for example. In other aspects, the lookuptables 4210 can store electrical signal waveforms shaped to maximize thepower delivered into the tissue per cycle (i.e., trapezoidal or squarewave). In other aspects, the lookup tables 4210 can store wave shapessynchronized in such way that they make maximizing power delivery by anyone of the surgical instruments of surgical system 1000 when deliveringRF and ultrasonic drive signals. In yet other aspects, the lookup tables4210 can store electrical signal waveforms to drive ultrasonic and RFtherapeutic, and/or sub-therapeutic, energy simultaneously whilemaintaining ultrasonic frequency lock. Generally, the output wave shapemay be in the form of a sine wave, cosine wave, pulse wave, square wave,and the like. Nevertheless, the more complex and custom wave shapesspecific to different instruments and their tissue effects can be storedin the non-volatile memory of the generator circuit or in thenon-volatile memory (e.g., EEPROM) of the surgical instrument and befetched upon connecting the surgical instrument to the generatorcircuit. One example of a custom wave shape is an exponentially dampedsinusoid as used in many high crest factor “coagulation” waveforms, asshown in FIG. 37.

FIG. 37 illustrates one cycle of a discrete time digital electricalsignal waveform 4300, in accordance with at least one aspect of thepresent disclosure of an analog waveform 4304 (shown superimposed overthe discrete time digital electrical signal waveform 4300 for comparisonpurposes). The horizontal axis represents Time (t) and the vertical axisrepresents digital phase points. The digital electrical signal waveform4300 is a digital discrete time version of the desired analog waveform4304, for example. The digital electrical signal waveform 4300 isgenerated by storing an amplitude phase point 4302 that represents theamplitude per clock cycle T_(cik) over one cycle or period T₀. Thedigital electrical signal waveform 4300 is generated over one period T₀by any suitable digital processing circuit. The amplitude phase pointsare digital words stored in a memory circuit. In the example illustratedin FIGS. 35 and 36, the digital word is a six-bit word that is capableof storing the amplitude phase points with a resolution of 26 or 64bits. It will be appreciated that the examples shown in FIGS. 35 and 36is for illustrative purposes and in actual implementations theresolution can be much higher. The digital amplitude phase points 4302over one cycle T₀ are stored in the memory as a string of string wordsin a lookup table 4104, 4210 as described in connection with FIGS. 35and 36, for example. To generate the analog version of the analogwaveform 4304, the amplitude phase points 4302 are read sequentiallyfrom the memory from 0 to T₀ per clock cycle T_(cik) and are convertedby a DAC circuit 4108, 4212, also described in connection with FIGS. 35and 36. Additional cycles can be generated by repeatedly reading theamplitude phase points 4302 of the digital electrical signal waveform4300 the from 0 to T₀ for as many cycles or periods as may be desired.The smooth analog version of the analog waveform 4304 is achieved byfiltering the output of the DAC circuit 4108, 4212 by a filter 4112,4214 (FIGS. 35 and 36). The filtered analog output signal 4114, 4222(FIGS. 35 and 36) is applied to the input of a power amplifier.

Ultrasonic Surgical Instrument Architecture

FIG. 38 illustrates one aspect of an ultrasonic system 137010. Oneaspect of the ultrasonic system 137010 comprises an ultrasonic signalgenerator 137012 coupled to an ultrasonic transducer 137014, a handpiece assembly 137060 comprising a hand piece housing 137016, and anultrasonic blade 137050. The ultrasonic transducer 137014, which isknown as a “Langevin stack,” generally includes a transduction portion137018, a first resonator or end-bell 137020, and a second resonator orfore-bell 137022, and ancillary components. In various aspects, theultrasonic transducer 137014 is preferably an integral number ofone-half system wavelengths (nλ/2) in length as will be described inmore detail below. An acoustic assembly 137024 can include theultrasonic transducer 137014, a mount 137026, a velocity transformer137028, and a surface 137030.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping the hand piece assembly137060. Thus, the ultrasonic blade 137050 is distal with respect to themore proximal hand piece assembly 137060. It will be further appreciatedthat, for convenience and clarity, spatial terms such as “top” and“bottom” also are used herein with respect to the clinician gripping thehand piece assembly 137060. However, surgical instruments are used inmany orientations and positions, and these terms are not intended to belimiting and absolute.

The distal end of the end-bell 137020 is connected to the proximal endof the transduction portion 137018, and the proximal end of thefore-bell 137022 is connected to the distal end of the transductionportion 137018. The fore-bell 137022 and the end-bell 137020 have alength determined by a number of variables, including the thickness ofthe transduction portion 137018, the density and modulus of elasticityof the material used to manufacture the end-bell 137020 and thefore-bell 137022, and the resonant frequency of the ultrasonictransducer 137014. The fore-bell 137022 may be tapered inwardly from itsproximal end to its distal end to amplify the ultrasonic vibrationamplitude of the velocity transformer 137028, or, alternately, fore-bell137022 may have no amplification.

Referring again to FIG. 38, end-bell 137020 can include a threadedmember extending therefrom which can be configured to be threadablyengaged with a threaded aperture in fore-bell 137022. In variousaspects, piezoelectric elements, such as piezoelectric elements 137032,for example, can be compressed between end-bell 137020 and fore-bell137022 when end-bell 137020 and fore-bell 137022 are assembled together.Piezoelectric elements 137032 may be fabricated from any suitablematerial, such as, for example, lead zirconate-titanate, leadmeta-niobate, lead titanate, and/or any suitable piezoelectric crystalmaterial, for example.

In various aspects, as discussed in greater detail below, transducer137014 can further comprise electrodes, such as positive electrodes137034 and negative electrodes 137036, for example, which can beconfigured to create a voltage potential across one or morepiezoelectric elements 137032. Each of the positive electrodes 137034,negative electrodes 137036, and the piezoelectric elements 137032 cancomprise a bore extending through the center which can be configured toreceive the threaded member of end-bell 137020. In various aspects, thepositive and negative electrodes 137034 and 137036 are electricallycoupled to wires 137038 and 137040, respectively, wherein the wires137038 and 137040 can be encased within a cable 137042 and electricallyconnectable to the ultrasonic signal generator 137012 of the ultrasonicsystem 137010.

In various aspects, the ultrasonic transducer 137014 of the acousticassembly 137024 converts the electrical signal from the ultrasonicsignal generator 137012 into mechanical energy that results in primarilylongitudinal vibratory motion of the ultrasonic transducer 137014 andthe ultrasonic blade 137050 at ultrasonic frequencies. An ultrasonicsurgical generator 137012 can include, for example, the generator 1100(FIG. 18) or the generator 137012 (FIG. 38). When the acoustic assembly137024 is energized, a vibratory motion standing wave is generatedthrough the acoustic assembly 137024. A suitable vibrational frequencyrange may be about 20 Hz to 120 kHz and a well-suited vibrationalfrequency range may be about 30-70 kHz and one example operationalvibrational frequency may be approximately 55.5k Hz.

The amplitude of the vibratory motion at any point along the acousticassembly 137024 may depend upon the location along the acoustic assembly137024 at which the vibratory motion is measured. A minimum or zerocrossing in the vibratory motion standing wave is generally referred toas a node (i.e., where motion is usually minimal), and an absolute valuemaximum or peak in the standing wave is generally referred to as ananti-node (i.e., where motion is usually maximal). The distance betweenan anti-node and its nearest node is one-quarter wavelength (λ/4).

As outlined above, the wires 137038, 137040 transmit an electricalsignal from the ultrasonic signal generator 137012 to the positiveelectrodes 137034 and the negative electrodes 137036. The piezoelectricelements 137032 are energized by the electrical signal supplied from theultrasonic signal generator 137012 in response to a foot switch 137044,for example, to produce an acoustic standing wave in the acousticassembly 137024. The electrical signal causes disturbances in thepiezoelectric elements 137032 in the form of repeated smalldisplacements resulting in large compression forces within the material.The repeated small displacements cause the piezoelectric elements 137032to expand and contract in a continuous manner along the axis of thevoltage gradient, producing longitudinal waves of ultrasonic energy.

In various aspects, the ultrasonic energy produced by transducer 137014can be transmitted through the acoustic assembly 137024 to theultrasonic blade 137050 via an ultrasonic transmission waveguide 137046.In order for the acoustic assembly 137024 to deliver energy to theultrasonic blade 137050, the components of the acoustic assembly 137024are acoustically coupled to the ultrasonic blade 137050. For example,the distal end of the ultrasonic transducer 137014 may be acousticallycoupled at the surface 137030 to the proximal end of the ultrasonictransmission waveguide 137046 by a threaded connection such as a stud137048.

The components of the acoustic assembly 137024 can be acoustically tunedsuch that the length of any assembly is an integral number of one-halfwavelengths (nλ/2), where the wavelength λ is the wavelength of apre-selected or operating longitudinal vibration drive frequency fd ofthe acoustic assembly 137024, and where n is any positive integer. It isalso contemplated that the acoustic assembly 137024 may incorporate anysuitable arrangement of acoustic elements.

The ultrasonic blade 137050 may have a length substantially equal to anintegral multiple of one-half system wavelengths (λ/2). A distal end137052 of the ultrasonic blade 137050 may be disposed at, or at leastnear, an antinode in order to provide the maximum, or at least nearlymaximum, longitudinal excursion of the distal end. When the transducerassembly is energized, in various aspects, the distal end 137052 of theultrasonic blade 137050 may be configured to move in the range of, forexample, approximately 10 to 500 microns peak-to-peak and preferably inthe range of approximately 30 to 150 microns at a predeterminedvibrational frequency.

As outlined above, the ultrasonic blade 137050 may be coupled to theultrasonic transmission waveguide 137046. In various aspects, theultrasonic blade 137050 and the ultrasonic transmission guide 137046 asillustrated are formed as a single unit construction from a materialsuitable for transmission of ultrasonic energy such as, for example,Ti6Al4V (an alloy of titanium including aluminum and vanadium),aluminum, stainless steel, and/or any other suitable material.Alternately, the ultrasonic blade 137050 may be separable (and ofdiffering composition) from the ultrasonic transmission waveguide137046, and coupled by, for example, a stud, weld, glue, quick connect,or other suitable known methods. The ultrasonic transmission waveguide137046 may have a length substantially equal to an integral number ofone-half system wavelengths (λ/2), for example. The ultrasonictransmission waveguide 137046 may be preferably fabricated from a solidcore shaft constructed out of material that propagates ultrasonic energyefficiently, such as titanium alloy (i.e., Ti6Al4V) or an aluminumalloy, for example.

In the aspect illustrated in FIG. 38, the ultrasonic transmissionwaveguide 137046 comprises a plurality of stabilizing silicone rings orcompliant supports 137056 positioned at, or at least near, a pluralityof nodes. The silicone rings 137056 can dampen undesirable vibration andisolate the ultrasonic energy from a sheath 137058 at least partiallysurrounding waveguide 137046, thereby assuring the flow of ultrasonicenergy in a longitudinal direction to the distal end 137052 of theultrasonic blade 137050 with maximum efficiency.

As shown in FIG. 38, the sheath 137058 can be coupled to the distal endof the handpiece assembly 137060. The sheath 137058 generally includesan adapter or nose cone 137062 and an elongated tubular member 137064.The tubular member 137064 is attached to and/or extends from the adapter137062 and has an opening extending longitudinally therethrough. Invarious aspects, the sheath 137058 may be threaded or snapped onto thedistal end of the housing 137016. In at least one aspect, the ultrasonictransmission waveguide 137046 extends through the opening of the tubularmember 137064 and the silicone rings 137056 can contact the sidewalls ofthe opening and isolate the ultrasonic transmission waveguide 137046therein. In various aspects, the adapter 137062 of the sheath 137058 ispreferably constructed from Ultem®, for example, and the tubular member137064 is fabricated from stainless steel, for example. In at least oneaspect, the ultrasonic transmission waveguide 137046 may have polymericmaterial, for example, surrounding it in order to isolate it fromoutside contact.

As described above, a voltage, or power source can be operably coupledwith one or more of the piezoelectric elements of a transducer, whereina voltage potential applied to each of the piezoelectric elements cancause the piezoelectric elements to expand and contract, or vibrate, ina longitudinal direction. As also described above, the voltage potentialcan be cyclical and, in various aspects, the voltage potential can becycled at a frequency which is the same as, or nearly the same as, theresonant frequency of the system of components comprising transducer137014, waveguide 137046, and ultrasonic blade 137050, for example. Invarious aspects, however, certain of the piezoelectric elements withinthe transducer may contribute more to the standing wave of longitudinalvibrations than other piezoelectric elements within the transducer. Moreparticularly, a longitudinal strain profile may develop within atransducer wherein the strain profile may control, or limit, thelongitudinal displacements that some of the piezoelectric elements cancontribute to the standing wave of vibrations, especially when thesystem is being vibrated at or near its resonant frequency.

The piezoelectric elements 137032 are configured into a “Langevinstack,” in which the piezoelectric elements 137032 and their activatingelectrodes 137034 and 137036 (together, transducer 137014) areinterleaved. The mechanical vibrations of the activated piezoelectricelements 137032 propagate along the longitudinal axis of the transducer137014, and are coupled via the acoustic assembly 137024 to the end ofthe waveguide 137046. Such a mode of operation of a piezoelectricelement is frequently described as the D33 mode of the element,especially for ceramic piezoelectric elements comprising, for example,lead zirconate-titanate, lead meta-niobate, or lead titanate. The D33mode of a ceramic piezoelectric element is illustrated in FIGS. 39A-39C.

FIG. 39A depicts a piezoelectric element 137200 fabricated from aceramic piezoelectric material. A piezoelectric ceramic material is apolycrystalline material comprising a plurality of individualmicrocrystalline domains. Each microcrystalline domain possesses apolarization axis along which the domain may expand or contract inresponse to an imposed electric field. However, in a native ceramic, thepolarization axes of the microcrystalline domains are arranged randomly,so there is no net piezoelectric effect in the bulk ceramic. A netre-orientation of the polarization axes may be induced by subjecting theceramic to a temperature above the Curie temperature of the material andplacing the material in a strong electrical field. Once the temperatureof the sample is dropped below the Curie temperature, a majority of theindividual polarization axes will be re-oriented and fixed in a bulkpolarization direction. FIG. 39A illustrates such a piezoelectricelement 137200 after being polarized along the inducing electric fieldaxis P. While the un-polarized piezoelectric element 137200 lacks anynet piezoelectric axis, the polarized element 137200 can be described aspossessing a polarization axis, d3, parallel to the inducing field axisP direction. For completeness, an axis orthogonal to the d3 axis may betermed a d1 axis. The dimensions of the piezoelectric element 137200 arelabeled as length (L), width (W), and thickness (T).

FIGS. 39B and 39C illustrate the mechanical deformations of apiezoelectric element 137200 that may be induced by subjecting thepiezoelectric element 137200 to an actuating electrical field E orientedalong the d3 (or P) axis. FIG. 39B illustrates the effect of an electricfield E having the same direction as the polarization field P along thed3 axis on a piezoelectric element 137205. As illustrated in FIG. 39B,the piezoelectric element 137205 may deform by expanding along the d3axis while compressing along the d1 axis. FIG. 39C illustrates theeffect of an electric field E having the opposing direction to thepolarization field P along the d3 axis on a piezoelectric element137210. As illustrated in FIG. 39C, the piezoelectric element 137210 maydeform by compressing along the d3 axis, while expanding along the d1axis. Vibrational coupling along the d3 axis during the application ofan electric field along the d3 axis may be termed D33 coupling oractivation using a D33 mode of a piezoelectric element. The transducer137014 illustrated in FIG. 1 can use the D33 mode of the piezoelectricelements 137032 for transmitting mechanical vibrations along thewaveguide 46 to the ultrasonic blade 137050. Because the piezoelectricelement also deforms along the d1 axis, vibrational coupling along thed1 axis during the application of an electric field along the d3 axismay also be an effective source of mechanical vibrations. Such couplingmay be termed D31 coupling or activation using a D31 mode of apiezoelectric element.

As illustrated by FIGS. 39A-39C, during operation in the D31 mode,transverse expansion of piezoelectric elements 137200, 137205, 137210may be mathematically modeled by the following equation:

$\frac{\Delta \; L}{L} = {\frac{\Delta \; W}{W} = \frac{V_{d\; 31}}{T}}$

In the equation, L, W, and T refer to the length, width and thicknessdimensions of a piezoelectric element, respectively. V_(d31) denotes thevoltage applied to a piezoelectric element operating in the D31 mode.The quantity of transverse expansion resulting from the D31 couplingdescribed above is represented by ΔL (i.e., expansion of thepiezoelectric element along the length dimension) and ΔW (i.e.,expansion of the piezoelectric element along the width dimension).Additionally, the transverse expansion equation models the relationshipbetween ΔL and ΔW and the applied voltage V_(d31). Disclosed below areaspects of ultrasonic surgical instruments based on D31 activation by apiezoelectric element.

In various aspects, as described below, an ultrasonic surgicalinstrument can comprise a transducer configured to produce longitudinalvibrations, and a surgical instrument having a transducer base plate(e.g., a transducer mounting portion) operably coupled to thetransducer, an end effector, and waveguide therebetween. In certainaspects, as also described below, the transducer can produce vibrationswhich can be transmitted to the end effector, wherein the vibrations candrive the transducer base plate, the waveguide, the end effector, and/orthe other various components of the ultrasonic surgical instrument at,or near, a resonant frequency. In resonance, a longitudinal strainpattern, or longitudinal stress pattern, can develop within thetransducer, the waveguide, and/or the end effector, for example. Invarious aspects, such a longitudinal strain pattern, or longitudinalstress pattern, can cause the longitudinal strain, or longitudinalstress, to vary along the length of the transducer base plate,waveguide, and/or end effector, in a sinusoidal, or at leastsubstantially sinusoidal, manner. In at least one aspect, for example,the longitudinal strain pattern can have maximum peaks and zero points,wherein the strain values can vary in a non-linear manner between suchpeaks and zero points.

FIG. 40 illustrates an ultrasonic surgical instrument 137250 thatincludes an ultrasonic waveguide 137252 attached to an ultrasonictransducer 137264 by a bonding material, where the ultrasonic surgicalinstrument 137250 is configured to operate in a D31 mode, according toone aspect of this disclosure. The ultrasonic transducer 137264 includesfirst and second piezoelectric elements 137254 a, 137254 b attached tothe ultrasonic waveguide 137252 by a bonding material. The piezoelectricelements 137254 a, 137254 b include electrically conductive plates137256 a, 137256 b to electrically couple one pole of a voltage sourcesuitable to drive the piezoelectric elements 137254 a, 137254 b (e.g.,usually a high voltage). The opposite pole of the voltage source iselectrically coupled to the ultrasonic waveguide 137252 by electricallyconductive joints 137258 a, 137258 b. In one aspect, the electricallyconductive plates 137256 a, 137256 b are coupled to a positive pole ofthe voltage source and the electrically conductive joints 137258 a,137258 b are electrically coupled to ground potential through the metalultrasonic waveguide 137252. In one aspect, the ultrasonic waveguide137252 is made of titanium or titanium alloy (i.e., Ti6Al4V) and thepiezoelectric elements 137254 a, 137254 b are made of PZT. The polingaxis (P) of the piezoelectric elements 137254 a, 137254 b is indicatedby the direction arrow 137260. The motion axis of the ultrasonicwaveguide 137252 in response to excitation of the piezoelectric elements137254 a, 137245 b is shown by a motion arrow 137262 at the distal endof the ultrasonic waveguide 137252 generally referred to as theultrasonic blade portion of the ultrasonic waveguide 137252. The motionaxis 137262 is orthogonal to the poling axis (P) 137260.

In conventional D33 ultrasonic transducer architectures as shown in FIG.38, the bolted piezoelectric elements 137032 utilize electrodes 137034,137036 to create electrical contact to both sizes of each piezoelectricelement 137033. The D31 architecture 137250 according to one aspect ofthis disclosure, however, employs a different technique to createelectrical contact to both sides of each piezoelectric element 137254 a,137254 b. Various techniques for providing electrical contact to thepiezoelectric elements 137254 a, 137254 b include bonding electricalconductive elements (e.g., wires) to the free surface of eachpiezoelectric element 137254 a, 137254 b for the high potentialconnection and bonding each piezoelectric element 137254 a, 137254 b theto the ultrasonic waveguide 137252 for the ground connection usingsolder, conductive epoxy, or other techniques described herein.Compression can be used to maintain electrical contact to the acoustictrain without making a permanent connection. This can cause an increasein device thickness and should be controlled to avoid damaging thepiezoelectric elements 137254 a, 137254 b. Low compression can damagethe piezoelectric element 137254 a, 137254 b by a spark gap and highcompression can damage the piezoelectric elements 137254 a, 137254 b bylocal mechanical wear. In other techniques, metallic spring contacts maybe employed to create electrical contact with the piezoelectric elements137254 a, 137254 b. Other techniques may include foil-over-foam gaskets,conductive foam, and solder. In some aspects, there is an electricalconnection to both sides of the piezoelectric elements 137254 a, 137254b in the D31 acoustic train configuration. The electrical groundconnection can be made to the metal ultrasonic waveguide 137252, whichis electrically conductive, if there is electrical contact between thepiezoelectric elements 137254 a, 137254 b and the ultrasonic waveguide137252.

In conventional D33 ultrasonic transducer architectures as shown in FIG.38, a bolt provides compression that acoustically couples thepiezoelectric elements rings to the ultrasonic waveguide. The D31architecture 137250 according to one aspect of this disclosure employs avariety of different techniques to acoustically couple the piezoelectricelements 137254 a, 137254 b to the ultrasonic waveguide 137252. Someillustrative techniques are disclosed in U.S. patent application Ser.No. 15/679,940, titled ULTRASONIC TRANSDUCER TECHNIQUES FOR ULTRASONICSURGICAL INSTRUMENT, filed Aug. 17, 2017, which is hereby incorporatedby reference in its entirety.

FIGS. 41 and 42 illustrate various views of an ultrasonic surgicalinstrument 137400. In various aspects, the surgical instrument 137400can be embodied generally as a pair of ultrasonic shears, as shown. Inaspects where the ultrasonic surgical instrument 137400 is embodied as apair of ultrasonic shears, the surgical instrument 137400 can include afirst arm 137412 a pivotably connected to a second arm 137412 b at apivot point 137413 (e.g., by a fastener). The first arm 137412 aincludes a clamp arm 137416 positioned at its distal end that includes acooperating surface (e.g., a pad) that is configured to cooperate withan ultrasonic blade 137415 extending distally from the second arm 137412b. The clamp arm 137416 and the ultrasonic blade 137415 can collectivelydefine an end effector 137410. Actuating the first arm 137412 a in afirst direction causes the clamp arm 137416 to pivot towards theultrasonic blade 137415 and actuating the first arm 137412 a in a seconddirection causes the clamp arm 137416 to pivot away from the ultrasonicblade 137415. In some aspects, the clamp arm 13716 further includes apad constructed from a polymeric or other compliant material and engagesthe ultrasonic blade 137415. The surgical instrument 137400 furtherincludes a transducer assembly, such as is described above with respectto FIGS. 38-40. The transducer assembly can be arranged in, e.g., a D31or D33 architecture. The surgical instrument 137400 further comprises ahousing 137414 enclosing various components of an ultrasonic system137010 (FIG. 38), including first and second piezoelectric elements137419 a, 137419 b of an ultrasonic transducer 137418 arranged in a D31architecture, a transducer base plate 137428 (e.g., a transducermounting portion) comprising flat faces on opposite sides to receive thepiezoelectric elements 137419 a, 137419 b, and a waveguide 137417 thatlongitudinally translates vibrations from the ultrasonic transducer137418 to the ultrasonic blade 137415. Further, the surgical instrument137400 is connectable to an ultrasonic signal generator for driving theultrasonic transducer 137418, as described above. The waveguide 137417can comprise a plurality of stabilizing silicone rings or compliantsupports 137411 positioned at, or at least near, a plurality of nodes(i.e., points located at a minimum or zero crossing in the vibratorymotion standing wave). The compliant supports 137411 are configured todampen undesirable lateral vibration in order to ensure that ultrasonicenergy is transmitted longitudinally to the ultrasonic blade 137415. Thewaveguide 137417 extends through the housing 137414 and the second arm137412 b and terminates at the ultrasonic blade 137415, externally tothe housing 137414. The ultrasonic blade 137415 and the clamp arm 137416are cooperating elements that are configured to grasp tissue, allowingthe end effector 137410 to clamp and cut/coagulate tissue. Moving theclamp arm 137416 towards the ultrasonic blade 137415 causes tissuesituated therebetween to contact the ultrasonic blade 137415, allowingthe ultrasonic blade 137415 to operate against the grasped tissue. Asthe ultrasonic blade 137415 ultrasonically vibrates against the gaspedtissue, the ultrasonic blade 137415 generates frictional forces thatcause the tissue to coagulate and eventually sever along the cuttinglength of the ultrasonic blade 137415.

The cutting length of the surgical instrument 137400 corresponds to thelengths of the ultrasonic blade 137415 and the cooperating surface ofthe clamp arm 137416. Tissue that is held between the ultrasonic blade137415 and the cooperating surface of the clamp arm 137416 for asufficient period of time is cut by the ultrasonic blade 137415, asdescribed above. The ultrasonic blade 137415 and the correspondingportion of the clamp arm 137416 can have a variety of shapes. In variousaspects, the ultrasonic blade 137415 and/or clamp arm 137416 can besubstantially linear in shape or have a curvature. In some aspects, theportion of the clamp arm 137416 configured to bring tissue into contactwith the ultrasonic blade 137415 can correspond to the shape of theultrasonic blade 137415 so that the clamp arm 137416 is alignedtherewith.

Various additional details regarding ultrasonic transducer assembliesand ultrasonic shears can be found in U.S. patent application Ser. No.15/679,940, titled ULTRASONIC TRANSDUCER TECHNIQUES FOR ULTRASONICSURGICAL INSTRUMENT, filed Aug. 17, 2017, which is hereby incorporatedby reference in its entirety.

Advanced Energy Device Activation Options

FIG. 43 illustrates a block diagram of a surgical system 137500, inaccordance with at least one aspect of the present disclosure. Thesurgical system 137500 can include, for example, the surgical system1000 depicted in FIG. 20 and/or the ultrasonic surgical instrumentsystem 137010 depicted in FIG. 38. The surgical system 137500 caninclude a surgical instrument 137400, such as the ultrasonic surgicalinstrument 1104 (FIG. 18) or the ultrasonic surgical instrument 137300(FIG. 29), that is electrically connectable to an electrosurgicalgenerator 137504, such as generator 1100 (FIG. 18) or the generator137012 (FIG. 38), capable of producing ultrasonic energy, monopolar orbipolar radiofrequency (RF) energy, other types of energy, and/orcombinations thereof for driving the surgical instrument 137400.

In the aspect depicted in FIG. 43, the surgical instrument 137400includes a transducer assembly 137510 that comprises at least twopiezoelectric elements. The transducer assembly 137510 is operablycoupled to the ultrasonic blade 137512 such that the transducer assembly137510 can ultrasonically oscillate the ultrasonic blade 137512 whenthen transducer assembly 137510 is activated, as is described inconnection with FIGS. 38-40. The transducer assembly 137510 is in turnelectrically coupled to the generator 137504 to receive energytherefrom. Accordingly, when energized by the generator 137504, thetransducer assembly 137510 is configured to ultrasonically oscillate theultrasonic blade 137512 in order to sever and/or coagulate tissuecaptured by the surgical instrument 137400.

In another aspect, the surgical instrument 137400 includes one or moreelectrodes 796 (FIG. 17) or other conducting elements located at the endeffector 792 (FIG. 17). The electrodes 796 are in turn electricallycoupled to the generator 137504 to receive energy therefrom. Whenenergized by the generator 137504, the electrodes 796 are configured toapply RF energy in order to sever and/or coagulate tissue captured bythe surgical instrument 137400, as is described in connection with FIG.17.

The surgical instrument 137400 further includes a control circuit 137506that is communicably coupled to a sensor 137508 and communicablycouplable to the generator 137504. The control circuit 137506 caninclude, for example, a processor coupled to primary and/or secondarycomputer memory for executing instructions stored on the memory, amicrocontroller, an application-specific integrated circuit (ASIC), afield-programmable gate array (FPGA), and other such devices. The sensor137508 is configured to sense a property of the environment and/or thesurgical instrument 137400 and provide an output corresponding to thepresence or magnitude of the sensed property. The control circuit 137506is in turn configured to selectively control the activation of thetransducer assembly 137510 and/or electrodes 796 according to whetherthe sensed property is above, below, or at a threshold value. In otherwords, the control circuit 137506 is configured to control theactivation of the transducer assembly 137510 and/or electrodes 796according to the sensor output relative to a threshold. In one aspect,the threshold can be stored in a memory of the surgical instrument137400 and retrieved by the control circuit 137506 to compare the outputsignal from the sensor 137508 thereagainst.

In various other exemplifications, the control circuit 137506 and/orsensor 137508 may be external to the surgical instrument 137400. Inthese exemplifications, the control circuit 137506 and/or sensor 137508can be communicably coupled to each other and/or the generator 137504via any wired communication protocol (e.g., I²C) or wirelesscommunication protocol (e.g., Bluetooth) and include the appropriatehardware and/or software to effectuate the particular communicationprotocol. In still other exemplifications, the generator 137504 can beintegral, internal, or otherwise incorporated with the surgicalinstrument 137400, rather than being external thereto, as depicted inFIG. 18 and FIG. 38.

FIGS. 44-45C illustrate various views of a surgical instrument 137400including a sensor assembly 137508 configured to detect a magneticreference 137404, in accordance with at least one aspect of the presentdisclosure. In the following description of FIGS. 44-45C, referenceshould also be made to FIG. 43. In one aspect, the sensor assembly137508 includes a sensor 137402 that is configured to detect theposition or state (e.g., opened or closed) of the surgical instrument137400 by detecting the corresponding position or location of a magneticreference 137404. The sensor 137402 can include, for example, a Halleffect sensor that is configured to detect the location of the magneticreference 137404 relative thereto. Accordingly, the magnetic reference137404 is configured such that its position corresponds to the positionand/or state of the surgical instrument 137400. The Hall effect sensorcan include, for example, a Hall element configured to detect therelative distance between the magnetic reference 137404 and the sensor137402 or an assembly of multiple Hall elements configured to detect themultidimensional position or orientation of the magnetic reference137404 relative to the sensor 137402 (e.g., a TLV493D-A1B6 3D magneticsensor from Infineon Technologies). Further, the Hall effect sensor caninclude linear Hall effect sensors (i.e., Hall effect sensors where theoutput varies linearly with the magnetic flux density) or threshold Halleffect sensors (i.e., Hall effect sensors where the output drops sharplyaccording to decreasing magnetic flux density).

In the aspect depicted in FIG. 44, the magnetic reference 137404includes a wearable magnet 137406. Accordingly, the sensor 137402 isconfigured to detect the relative position of the wearable magnet 137406as worn, for example, on the hand of a surgeon. In various aspects, therelative position of the wearable magnet 137406 with respect to thesensor 137402 can include, for example, the relative distance betweenthe wearable magnet 137406 and the sensor 137402 and/or the relativeorientation of the wearable magnet 137406 with respect to the sensor137402. In one example, the wearable magnet 137406 can be incorporatedwith or positioned in or on a ring that is worn on a finger of thesurgeon (e.g., over a surgical glove). In another example, the wearablemagnet 137406 can be attached or integral to a surgical glove wearableby the surgeon. In these aspects, as the wearable magnet 137406 islocated on the surgeon's hand and the surgeon's hand grips the arm137412 of the surgical instrument 137400 during use thereof, theposition of the wearable magnet 137406 as detected by the sensor 137402corresponds to the relative position of the arm 137412 of the surgicalinstrument 137400. By sensing the relative position of the arm 137412 ofthe surgical instrument 137400, the control circuit 137506 can therebydetermine whether the surgical instrument 137400 is opened, closed, orin an intermediate position therebetween.

In another exemplification, the positions of the wearable magnet 137406and the sensor 137402 can be reversed from the aspect described above.In other words, the magnet can be positioned on or in the surgicalinstrument 137400 and the sensor 137402 can be positioned on or worn bythe surgeon (e.g., incorporated into a ring or a surgical glove, asdescribed above). Otherwise, this exemplification functions in a similarmanner to the exemplification that is described above.

In the aspect depicted in FIGS. 45A-C, the magnetic reference 137404includes an integral magnet 137408 positioned in or on a movablecomponent of the surgical instrument 137400, such as the arm 137412thereof. Accordingly, the sensor 137402 is configured to detect therelative position of the integral magnet 137408 within the arm 137412 ofthe surgical instrument 137400. The integral magnet 137408 and thesensor 137402 can each be positioned such that opening and closing thesurgical instrument 137400 causes the integral magnet 137408 to moverelative to the sensor 137402. In the depicted aspect, the integralmagnet 137408 can be positioned on or in the movable arm 137412 of thesurgical instrument 137400 and the sensor 137402 can be positioned on orin the housing 137414 of the surgical instrument 137400. In theseaspects, the position of the integral magnet 137408 detected by thesensor 137402 corresponds to the relative position of the arm 137412 ofthe surgical instrument 137400. By sensing the relative position of thearm 137412 of the surgical instrument 137400, the control circuit 137506can thereby determine whether the surgical instrument 137400 is opened,closed, or in an intermediate position therebetween.

In another exemplification, the positions of the integral magnet 137408and the sensor 137402 can be reversed from the aspect described above.In other words, the integral magnet 137408 can be positioned on or inthe housing 137414 of the surgical instrument 137400 and the sensor137402 can be positioned on or in the corresponding movable component(e.g., the arm 137412) of the surgical instrument 137400 that is beingtracked. Otherwise, this exemplification functions in a similar mannerto the exemplification that is described above.

The sensor 137402 is configured to produce an output that corresponds tothe position of the magnetic reference 137404 relative thereto (e.g.,the distance between the magnetic reference 137404 and the sensor 137402and/or the orientation of the magnetic reference 137404 with respect tothe sensor 137402). Thus, as the magnetic reference 137404 and/or thesensor 137402 move with respect to each other as the surgical instrument137400 is closed, opened, or otherwise manipulated by a surgeon, thesensor 137400 is able to detect the relative position of the magneticreference 137404 according to the sensed magnetic field of the magneticreference 137404. The sensor 137402 can then produce an outputcorresponding to the sensed magnetic field of the magnetic reference137404. In one aspect where the sensor 137402 includes a Hall effectsensor, the sensor output can be a voltage, wherein the magnitude of theoutput voltage corresponds to the strength of the magnetic field fromthe magnetic reference 137404 sensed by the sensor 137402.

In one aspect, the control circuit 137506 is configured to receive theoutput from the sensor 137402 and then compare the output of the sensor137402 to a threshold. The control circuit 137506 can further activateor deactivate the surgical instrument 137400 according the comparisonbetween the output of the sensor 137402 and the threshold. The thresholdcan be, e.g., predetermined or set by a user of the surgical instrument137400. The output of the sensor 137402 can correspond to the positionof the arm of the surgical instrument 137400 (either directly, as in theaspect depicted in FIGS. 45A-C, or indirectly, as in the aspect depictedin FIG. 44), which in turn controls the position of the clamp arm 137416(FIG. 41) relative to the ultrasonic blade 137512. Therefore, the outputof the sensor 137402 corresponds to the position of the clamp arm 137416of the surgical instrument 137402 between, e.g., an open position and aclosed position. Further in these exemplifications, the threshold cancorrespond to a threshold distance between the magnetic reference 137404and the sensor 137402. FIG. 45B, for example, can represent an openposition for the surgical instrument 137400 (i.e., the integral magnet137408 is not within a threshold distance to the sensor 137402) and FIG.45C, for example, can represent a closed position of the surgicalinstrument 137400 (i.e., the integral magnet 137408 is within athreshold distance to the sensor 137402).

In one example, the control circuit 137506 can determine whether themagnetic reference 137404 is positioned less than or equal to athreshold distance from the sensor 137402. In this example, if thecontrol circuit 137506 determines that the sensor output exceeds thethreshold, then the control circuit 137506 can activate the surgicalinstrument 137400. In another example, the control circuit 137506 candetermine whether the magnetic reference 137404 is positioned greaterthan or equal to a threshold distance from the sensor 137402. In thisexample, if the control circuit 137506 determines that the voltageoutput of the sensor 137402 is less than or equal to the threshold, thenthe control circuit 137506 can activate the surgical instrument 137400.The control circuit 137506 can activate the surgical 137400 bytransmitting a signal to the generator 137504 that cause the generator137504 to energize the transducer assembly 137510 and/or RF electrodes796 to cut and/or coagulate tissue captured by the surgical instrument137400. In sum, in some aspects the control circuit 137506 can beconfigured to determine whether the surgical instrument 137400 issufficiently closed and, if it is, then activate the surgical instrument137400.

In other aspects, the control circuit 137506 can be configured takeother actions if it determines that the surgical instrument 137400 issufficiently closed, such as providing a prompt to the user ortransmitting data to a surgical hub 106, as described in connection withFIGS. 1-11. In still other aspects, the control circuit 137506 can beconfigured to determine whether the surgical instrument 137400 issufficiently opened or at some particular position (or range ofpositions) between the opened and closed positions. If the surgicalinstrument 137400 is at or within the defined position(s), the controlcircuit 137506 can accordingly activate the surgical instrument 137400,deactivate the surgical instrument 137400, or take a variety of otheractions.

In some aspects, the control circuit 137506 can be configured to detecttapping, rubbing, and other types of motions based upon the amplitude,frequency, and/or direction of the motion of the magnetic reference137404 detected via the sensor 137402. Such motions can be detectedbecause the change in the strength of the magnetic field over timedetected by the sensor 137402 can be characterized (empirically orotherwise) and defined for different types of motions. For example, atapping motion could be detectable according to the frequency in thechange of the magnetic field detected by the sensor 137402 in adirection substantially perpendicular to the longitudinal axis of thesurgical instrument 137400. As another example, a rubbing motion couldbe detectable according to the frequency in the change of the magneticfield detected by the sensor 137402 in a direction substantiallyparallel to the longitudinal axis of the surgical instrument 137400. Insome aspects, the control circuit 137506 can be configured to change thestate, mode, and/or properties of the surgical instrument 137400according to the detected motions. For example, the control circuit137506 could be configured to activate the surgical instrument 137400upon detecting a tapping motion via the sensor 137402.

FIGS. 46A-B illustrates perspective views of a surgical instrument137400 including a sensor assembly 137508 configured to detect contactthereagainst and FIG. 47 illustrates a corresponding circuit diagram, inaccordance with at least one aspect of the present disclosure. In thefollowing description of FIGS. 46A-47, reference should also be made toFIG. 43. In one aspect, the sensor assembly 137508 can include a touchsensor 137420 that is configured to detect force, contact, and/orpressure thereagainst. The touch sensor 137420 can comprise, e.g., aforce-sensitive resistor (FSR) 137421. In one exemplification depictedin FIG. 46A, the touch sensor 137420 is oriented transverse to thelongitudinal axis of the surgical instrument 137400. In thisexemplification, the touch sensor 137420 defines a surface extendingorthogonally from the housing 137414 relative to the longitudinal axisof the surgical instrument 137400. In another exemplification depictedin FIG. 46B, the touch sensor 137420 extends along the lateralsurface(s) of the housing 137414. In this exemplification, the touchsensor 137420 can be integral to or positioned in or on the housing137414 of the surgical instrument 137400. In either of theseexemplifications, the touch sensor 137420 can be utilized by a surgeonto, e.g., activate the transducer assembly 137510 of the surgicalinstrument 137400 or otherwise provide input to the surgical instrument137400 (e.g., in order to control one or more functions of the surgicalinstrument 137400).

In one aspect where the touch sensor 137420 includes a FSR 137421, asdepicted in FIG. 47, the surgical instrument 137400 can include acircuit to control the activation of the electrosurgical generator137426 electrically connectable to the surgical instrument 137400. Inthis exemplification, the FSR 137421 is electrically coupled to ananalog-to-digital converter (ADC) 137422 and a control circuit 137424(e.g., a microcontroller or an ASIC). As a force F is applied to the FSR137421, the voltage output of the FSR 137721 varies accordingly. The ADC137422 then converts the analog signal from the FSR 137421 to a digitalsignal, which is then supplied to the control circuit 137424. In oneexemplification, the control circuit 137424 can then compare thereceived signal (which is indicative of the output voltage of the FSR137421, which in turn is indicative of the force F or pressureexperienced by the FSR 137421) to a threshold to determine whether toactivate the electrosurgical generator 137426. In one exemplification,if the received signal does exceed the threshold, the control circuit137424 can transmit a signal to the electrosurgical generator 137426 toactivate it and energize the transducer assembly 137510 and/or RFelectrodes 796 to cut and/or coagulate tissue captured by the surgicalinstrument 137400. In another exemplification, the control circuit137424 can transmit the output of the FSR 137421 or a signal indicativethereof to a control circuit of the electrosurgical generator 137426,which then compares the received signal (which is indicative of theforce F or pressure experienced by the FSR 137421) to a threshold todetermine whether to activate electrosurgical generator 137426. If thereceived signal does exceed the threshold, the control circuit of theelectrosurgical generator 137426 can cause the electrosurgical generator137426 to begin suppling energy (via, e.g., a drive signal) to thetransducer assembly 137510 of the surgical instrument 137400 that iselectrically connected thereto. In sum, in some aspects the controlcircuit 137506 can determine whether a sufficient amount of force isbeing applied to the touch sensor 137420 and then activate thetransducer assembly 137510 accordingly.

FIGS. 48A-C illustrate perspective views of a surgical instrument 137400including a sensor assembly 137429 configured to detect closure of thesurgical instrument 137400, in accordance with at least one aspect ofthe present disclosure. In the following description of FIGS. 48A-C,reference should also be made to FIG. 43. In one aspect, the closuresensor assembly 137429 can include a closure sensor 137430 configured todetect when the arm 137412 of the surgical instrument 137400 is in aclosed position and, in some aspects, whether additional force is beingapplied to the arm 137412 after the surgical instrument 137400 is in theclosed position. In one exemplification, the closure sensor 137430comprises a two-stage tactile switch that is configured to detect, at afirst stage, when the arm of the surgical instrument is in a closedposition and, further, is configured to detect, at a second stage, whenadditional force or pressure is being applied after the arm 137412 ofthe surgical instrument 137400 is in the closed position. Such a closuresensor 137430 can be utilized to, for example, allow the surgicalinstrument 137400 to be closed without necessarily automaticallyactivating the transducer assembly 137510 and/or RF electrodes 796.

In one aspect depicted in FIGS. 48A-C, the closure sensor 137430 ispositioned on the housing 137414 such that the arm 137412 engages theclosure sensor 137430 when the arm 137412 is rotated in a firstdirection R₁ into a closed position, as shown in FIG. 48B, from an openposition, as shown in FIG. 48A. When the arm 137412 is in the closedposition, the arm 137412 can bottom out against the housing 137414(shroud) and/or the closure sensor 137430. When the surgical instrument137400 is opened (or otherwise not closed) or when the arm 137412 of thesurgical instrument 137400 is closed, but no additional force is beingapplied thereto, the closure sensor 137430 can be in the first positionor the first state, as depicted in FIG. 48B. When the arm 137412 of thesurgical instrument 137400 is closed and an additional force F₁ isapplied to the arm 137412, the closure sensor 137430 can be in thesecond position or the second state, as depicted in FIG. 48C. In someaspects, when the arm 137412 is in the initial closed position, the arm137412 can be at a first angle θ₁ from the housing 137414, and when aforce F₁ is applied to the arm 137412 in the initial closed position,the force F₁ can cause the closure sensor 137430 to depress, such thatthe arm 137412 is a second angle θ₂ from the housing 137414.

In one aspect, the output of the closure sensor 137430 can varyaccording to the position and/or state that the closure sensor 137430 isin. In other words, when the closure sensor 137430 is in the firststate, it can provide a first output to the control circuit 137506 ofthe surgical instrument 137400, and when the closure sensor 137430 is inthe second state, it can provide a second output to the control circuit137506 of the surgical instrument 137400. Thus, the closure sensor137430 can be configured to detect whether (i) the surgical instrument137400 is closed and (ii) when the surgical instrument 137400 is closed,whether additional force is being applied. In one aspect, the transducerassembly 137510 and/or RF electrodes 796 can be activated and/orsupplied energy only when the closure sensor 137430 is in the secondstate/position. This aspect would allow surgeons to activate thesurgical instrument 137400 solely through manipulation of the arm137412, but without losing the ability to grasp and manipulate tissueabsent activation of the activation of the transducer assembly 137510and/or RF electrodes 796.

In one aspect, the control circuit 137506 is configured to receive theoutput from the closure sensor 137430 and then compare the output of theclosure sensor 137430 to a threshold to determine whether the closuresensor 137430 is in the second position/state. The threshold can be,e.g., predetermined or set by a user of the surgical instrument 137400.In the exemplifications described above where the closure sensor 137430detects whether the arm 137412 of the surgical instrument 137400 isbeing closed and, further, whether additional force is being applied tothe arm 137412 when the arm 137412 is closed, the output of the closuresensor 137430 thus varies accordingly. Further in theseexemplifications, the threshold can correspond to a threshold forcebeing applied to the arm 137412 (and thus the closure sensor 137430)after the arm 137412 is closed. For example, if the control circuit137506 determines that the closure sensor 137430 output exceeds thethreshold, then the control circuit 137506 can activate the transducerassembly 137510 and/or RF electrodes 796 by sending a signal to thegenerator 137504 that cause the generator 137504 to begin supplyingenergy to the transducer assembly. In sum, in some aspects the controlcircuit 137506 can determine whether a sufficient amount of force isbeing applied to the closed arm 137412 of the surgical instrument 137400and, if it is, then activate the transducer assembly 137510 and/or RFelectrodes 796.

FIGS. 49A-F illustrates various views of a surgical instrument 137400including a sensor assembly 137439 configured to detect opening of thesurgical instrument 137400, in accordance with at least one aspect ofthe present disclosure. In the following description of FIGS. 49A-F,reference should also be made to FIG. 43. In one aspect, the openingsensor assembly 137439 includes an opening sensor 137440 that isconfigured to detect when the arm 137412 of the surgical instrument137400 is rotated in a second direction R₂ into an open position. In oneexemplification, the opening sensor 137440 comprises a tactile switch(e.g., a one-stage tactile switch) that is configured to detect when thearm 137412 of the surgical instrument 137400 is in a sufficiently openposition. The opening sensor 137440 can be utilized to, for example,allow the surgical instrument 137400 to be energized when it is in afully or sufficiently open position for performing back (anterior)scoring and other such surgical techniques that utilize the applicationof electrosurgical or ultrasonic energy to unclamped tissue, withoutcausing the surgical instrument 137400 to be energized any time thesurgical instrument 137400 is opened to any degree.

In various aspects, the opening sensor 137440 can be positioned at oradjacently to the pivot point 137413 of the surgical instrument 137400.In one aspect depicted in FIGS. 49A-F, the opening sensor 137440 ispositioned within a recess 137443 on a first lateral portion of thehousing 137414. A corresponding tab 137442 is positioned on a secondlateral portion of the housing 137414 and is configured to move throughthe recess 137443 and contact the opening sensor 137440, applying aforce F₂ thereto, when the clamp arm 137416 of the surgical instrument137400 is sufficiently open (i.e., opened to at least a particularangle). When the opening sensor 137440 is uncontacted by the tab 137442,the opening sensor 137440 can be in the first position or the firststate. When the arm 137412 of the surgical instrument 137400 is openedto a sufficient angle such that the tab 137422 contacts the openingsensor 137440, the opening sensor 137440 can be in the second positionor the second state, as depicted in FIG. 49D. In one aspect, the outputof the opening sensor 137440 can vary according to the position and/orstate that the opening sensor 137440 is in. In other words, when theopening sensor 137440 is in the first state, it can provide a firstoutput to the control circuit 137506 of the surgical instrument 137400,and when the opening sensor 137440 is in the second state, it canprovide a second output to the control circuit 137506 of the surgicalinstrument 137400. Thus, the opening sensor 137440 is able to detectwhether the surgical instrument 137400 is opened at least to the anglethat causes the opening sensor 137440 to be triggered or activated(e.g., by a force F₂ being applied thereto). In one aspect, thetransducer assembly 137510 and/or RF electrodes 796 can be activatedand/or energized, as described above, only when the sensor is in thesecond state/position.

In one aspect, the control circuit 137506 is configured to receive theoutput from the opening sensor 137440 and then compare the output of theopening sensor 137440 to a threshold, where the threshold corresponds tothe opening sensor 137440 being in the second position/state. Thethreshold can be, e.g., predetermined or set by a user of the surgicalinstrument 137400. In the exemplifications described above where theopening sensor 137440 detects whether the arm 137412 of the surgicalinstrument 137400 is open to a particular angle, the output of theopening sensor 137440 thus varies accordingly. Further in theseexemplifications, the threshold can correspond to a threshold angle atwhich the arm 137412 of the surgical instrument 137400 is positioned. Inone aspect, if the control circuit 137506 determines that the output ofthe opening sensor 137440 exceeds the threshold, then the controlcircuit 137506 can activate the transducer assembly 137510 and/or RFelectrodes 796 by sending a signal to the generator 137504 that causethe generator 137504 to begin supplying energy to the transducerassembly 137510 and/or RF electrodes 796. In sum, in some aspects thecontrol circuit 137506 can determine whether the arm 137412 of thesurgical instrument 137400 is open to a sufficient angle and, if it is,then activate the transducer assembly 137510 and/or RF electrodes 796.

In certain aspects, the sensor assemblies for activating a surgicalinstrument 137400 described above in connection with FIGS. 44-49F can beimplemented in various combinations with each other. For example, FIG.50 illustrates an exemplification of a surgical instrument 137400 wherethe sensor assembly 137508 includes both the closure sensor assembly137429 described in connection with FIGS. 48A-C and the opening sensorassembly 137439 described in connection with FIGS. 49A-F. The variousaspects of sensor assemblies 137508 described herein can be combinedtogether in a surgical instrument 137400 in order to providesupplementary and/or alternative methods for activating and/or providinginput to the surgical instrument 137400. It should be noted that theexemplification depicted in FIG. 50 is intended to be merelyillustrative and other exemplifications of surgical instruments 137400can include any other combination of the aforementioned sensorassemblies 137508.

FIG. 51 illustrates a perspective view of a surgical instrumentcomprising a deactivation control 137450, in accordance with at leastone aspect of the present disclosure. In various aspects, the surgicalinstrument 137400 can include a deactivation control 137450 forcontrolling whether one or more of the various sensors of the surgicalinstrument 137400, such as various sensor assemblies 137508 describedabove with respect to FIGS. 44-49F, are active. The deactivation control137450 can include, for example, a physical toggle or switch disposed onthe housing 137414 of the surgical instrument 137400 or a touchscreendisplay. The deactivation control 137450 can be communicably coupled tothe control circuit 137506 of the surgical instrument 137400 and,depending upon the input from the deactivation control 137450, thecontrol circuit 137506 can, for example, deactivate the sensor assembly137508 controlled by the deactivation control 137450 or otherwise ignorethe output of or not take any actions in response to the output from thesensor assembly 137508 controlled by the deactivation control 137450.

In reference to FIGS. 41-51, the surgical instrument 137400 can furtherinclude an indicator, such as an LED, a display, and other such outputdevices. The indicator can be coupled to the control circuit 137506 andcontrolled thereby. In some aspects, the control circuit 137506 can beconfigured to activate the indicator in response to an input receivedfrom the sensor assembly 137508. For example, the control circuit 137506can be configured to activate the indicator when the control circuit137506 determines that the surgical instrument 137400 is in a closedposition (e.g., as sensed via a sensor assembly 137508).

Smart Retractor

FIG. 52 illustrates a perspective view of a retractor 137600 comprisinga sensor 137602, in accordance with at least one aspect of the presentdisclosure. In various aspects, a retractor 137600 for securing asurgical site opening 137650 can include a sensor 137602 that isremovably or integrally affixed thereto. In one aspect, the sensor137602 is removably affixable to the retractor 137600 via a magnet. Thesensor 137602 can be configured to detect when the retractor 137600 istapped, jostled, moved, or otherwise manipulated by a user (e.g., asurgeon). In one exemplification, the sensor 137602 can include avibration sensor (e.g., an ADIS16223 digital tri-axial vibration sensor)that is configured to detect vibration or movement by the retractor137600 to which the sensor 137602 is affixed. In one aspect, the sensor137602 can be reusable, i.e., the sensor 137602 can maintain itseffectiveness through sterilization processes (because the sensor 137602is affixed to a retractor 137600, which is in the surgical field, itwould be sterilized after being used in a surgical procedure if it wasto be reused). The sensor 137602 can be configured to detect differenttypes of motions or actions (e.g., tapping) by a user according to theamplitude, frequency, and/or direction of the detected motion orvibration of the retractor 137600.

The sensor 137602 can be configured to transmit a signal indicative ofthe detected vibration or movement of the retractor 137600. In oneaspect, the sensor 137602 can be communicably coupled to a surgicalinstrument 137606 (e.g., a surgical instrument or an electrosurgicalinstrument) and/or another device (e.g., a generator) via, for example,a wired connection 137604. Based upon the motion or movement detected bythe sensor 137602, the sensor 137602 can change the state of thesurgical instrument(s) 137606 and/or other device(s) that arecommunicably coupled to the sensor 137602. The state of the surgicalinstrument(s) 137606 and/or other device(s) can correspond to, forexample, a mode that the instrument(s) 137606 and/or device(s) are in ora property of the instrument(s) 137606 and/or device(s). For example,when the sensor 137602 detects that the retractor 137600 is beingtapped, the sensor 137602 can transmit a signal to a surgical instrument137606 that is communicably coupled with it that causes the surgicalinstrument to 137606 to change from an inactive state to an activatestate (or vice versa). As another example, when the sensor 137602detects that the retractor 137600 is being touched, the sensor 137602can transmit a signal to a surgical generator that is communicablycoupled with it that causes the generator to change from an inactivemode to an activate mode (or vice versa). In some aspects, the retractorsensor 137602 can be configured to transmit data and/or signals to asurgical hub 106, as described in connection with FIGS. 1-11, which canthen in turn take various actions, such as controlling the surgicalinstrument(s) 137606 and/or other device(s), as described above.

FIG. 53 illustrates a perspective view of a retractor 137902 comprisinga display in use at a surgical site 137900, in accordance with at leastone aspect of the present disclosure. A surgical retractor 137902 helpsthe surgeon and operating room professionals hold an incision or woundopen during surgical procedures. The surgical retractor 137902 aids inholding back underlying organs or tissues, allowing doctors/nursesbetter visibility and access to the exposed area. A retractor 137902 caninclude a display 137904 or other control device that is configured todisplay alerts and/or information associated with the surgical procedurebeing performed, provide a means of controlling the instruments ordevices being utilized during the course of the surgical procedure orthe environment in which the surgical procedure is being performed(e.g., the operating room), and perform other such functions. In thedepicted aspect, the control device is integral to the retractor 137902.In another aspect, the control device can include, for example, aportable electronic device including a touchscreen display (e.g., atablet computer) that is removably affixable to the retractor 137902. Inyet another aspect, the control device includes a flexible stickerdisplay that is attachable to the body/skin of the patient or anothersurface

In one aspect, the control device includes an input device (e.g., akeypad, a capacitive touchscreen, or a combination thereof) forreceiving input from a user; an output device (e.g., a display) forproviding alerts, information, or other output to a user; an energysource (e.g., a coin cell, a battery, a photovoltaic cell, or acombination thereof); and a network interface controller for acommunication protocol (e.g., Wi-Fi, Bluetooth) for communicablyconnecting the control device to surgical instruments, devices withinthe operating room (e.g., a surgical hub 106 as described in FIGS.1-11), and/or other equipment (surgical or otherwise). The controldevice can be configured to provide a graphical user interface (GUI) fordisplaying information to the user (e.g., a surgeon) and receiving inputor commands from the user. In one aspect, the control device furtherincludes a light source 137906 (e.g., an array of LEDs) that isconfigured to illuminate the surgical field of view 137908 that theretractor 137902 is being utilized to secure.

In one aspect, the control device is removably affixable to the surgicalretractor 137902. In another aspect, the control device is integral tothe retractor 137902, defining a “smart” surgical retractor 137902. Thesmart surgical retractor 137902 may comprise an input display operatedby the smart surgical retractor 137902. The smart surgical retractor137902 may comprise a wireless communication device to communicate witha device connected to a generator module coupled to the surgical hub.Using the input display of the smart surgical retractor 137902, thesurgeon can adjust power level or mode of the generator module to cutand/or coagulate tissue. If using automatic on/off for energy deliveryon closure of an end effector on the tissue, the status of automaticon/off may be indicated by a light, screen, or other device located onthe smart retractor housing. Power being used may be changed anddisplayed.

In various aspects, the control device can be configured to controlvarious functions of the surgical instruments that are communicablyconnected to the control device, such as the power parameters (e.g., foran electrosurgical instrument and/or an ultrasonic instrument) oroperating modes (e.g., “cut” and “coagulation” modes for anelectrosurgical instrument, or automatic) of the surgical instruments.In various aspects, the control device can be configured to displayinformation related to the surgical procedure being performed and/orinformation related to the equipment being used during the course of thesurgical procedure, such as the temperature of an ultrasonic blade (endeffector), alerts or alarms that are generated during the course of thesurgical procedure, or the location of nerves within the surgical field.The alerts or alarms can be generated by, for example, the surgicalinstruments and/or a surgical hub 106 to which the surgical instruments(or other modular surgical devices) are communicably connected. Invarious aspects, the control device can be configured to controlfunctions of the environment in which the surgical procedure is beingperformed (e.g., an operating room), such as the intensity and/orposition of the field lights within an operating room.

In various aspects, the control device can be configured to sense whatsurgical instruments or other equipment are within the vicinity of thecontrol device and then cause any surgical instruments or otherequipment that connected to the control device to pass their operationalcontrols to the control device. In one aspect, the smart surgicalretractor 137902 can sense or know what device/instrument the surgeon isusing, either through the surgical hub 106 or RFID or other deviceplaced on the device/instrument or the smart surgical retractor 137902,and provide an appropriate display. Alarms and alerts may be activatedwhen conditions require. Other features include displaying thetemperature of the ultrasonic blade, nerve monitoring, light source orfluorescence. The light source 137906 may be employed to illuminate thesurgical field of view 137908 and to charge photocells on single usesticker display that stick onto the smart retractor 137902. In anotheraspect, the smart surgical retractor 137902 may include an augmentedreality projected on the patient's anatomy (e.g., a vein viewer).

In other aspects, the control device can comprise a smart flexiblesticker display attachable to the body/skin of a patient. The smartflexible sticker display can be applied to, for example, the body/skinof a patient between the area exposed by the surgical retractors. In oneaspect, the smart flexible sticker display may be powered by light, anon board battery, or a ground pad. The flexible sticker display maycommunicate via short range wireless (e.g., Bluetooth) to a device, mayprovide readouts, lock power, or change power. The smart flexiblesticker display also comprises photocells to power the smart flexiblesticker display using ambient light energy. The flexible sticker displayincludes a display 137904 of a control panel user interface to enablethe surgeon to control devices or other modules coupled to the surgicalhub.

Various additional details regarding smart retractors can be found inU.S. patent application Ser. No. 15/940,686, titled DISPLAY OF ALIGNMENTOF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE, filed Mar. 29, 2018,which is hereby incorporated by reference in its entirety.

Situational Awareness

Referring now to FIG. 54, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206 (FIGS. 1-11),for example, is depicted. The timeline 5200 is an illustrative surgicalprocedure and the contextual information that the surgical hub 106, 206can derive from the data received from the data sources at each step inthe surgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step 5204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step 5206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step 5208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step 5210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step 5212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step 5214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step 5216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step 5204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step 5220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step 5224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 5224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step 5226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step 5228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/659,900, titled METHOD OF HUB COMMUNICATION,filed Apr. 19, 2018, which is herein incorporated by reference in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 102.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

Various aspects of the subject matter described herein are set out inthe following numbered examples:

Example 1

A surgical instrument comprising: an ultrasonic blade, an arm pivotablerelative to the ultrasonic blade between an open position and a closedposition, a transducer assembly coupled to the ultrasonic blade, asensor configured to sense a position of the arm between the openposition and the closed position, and a control circuit coupled to thetransducer assembly and the sensor. The transducer assembly comprises atleast two piezoelectric elements configured to ultrasonically oscillatethe ultrasonic blade. The control circuit is configured to activate thetransducer assembly according to a position of the arm detected by thesensor relative to a threshold position.

Example 2

The surgical instrument of Example 1, wherein the sensor comprises aHall effect sensor.

Example 3

The surgical instrument of Example 2, wherein the arm comprises a magnetdetectable by the Hall effect sensor.

Example 4

The surgical instrument of Example 2, wherein the Hall effect sensor isconfigured to detect a magnet disposed on a user.

Example 5

The surgical instrument of any one of Examples 1-4, wherein thethreshold position corresponds to the open position.

Example 6

The surgical instrument of any one of Examples 1-5, wherein thethreshold position corresponds to the closed position.

Example 7

A surgical instrument comprising: an ultrasonic blade, an arm pivotablerelative to the ultrasonic blade between an open position and a closedposition, a transducer assembly coupled to the ultrasonic blade, a firstsensor configured to sense a first force as the arm transitions to theclosed position, a second sensor configured to sense a second force asthe arm transitions to the open position, and a control circuit coupledto the transducer assembly, the first sensor, and the second sensor. Thetransducer assembly comprises at least two piezoelectric elementsconfigured to ultrasonically oscillate the ultrasonic blade. The controlcircuit is configured to activate the transducer assembly according tothe first force sensed by the first sensor relative to a first thresholdand the second force sensed by the second sensor relative to a secondthreshold.

Example 8

The surgical instrument of Example 7, wherein the first sensor comprisea tactile switch.

Example 9

The surgical instrument of Example 8, wherein the tactile switchcomprises a two-stage tactile switch.

Example 10

The surgical instrument of Example 9, wherein the first thresholdcorrespond to a second stage of the two-stage tactile switch.

Example 11

The surgical instrument of any one of Examples 7-10, wherein the firstsensor is disposed on a housing of the surgical instrument such that thearm bears thereagainst as the arm transitions to the closed position.

Example 12

The surgical instrument of any one of Examples 7-11, wherein the secondsensor comprise a tactile switch.

Example 13

The surgical instrument of Example 12, wherein the tactile switchcomprises a one-stage tactile switch.

Example 14

The surgical instrument of any one of Examples 7-13, wherein the secondthreshold correspond to a non-zero force.

Example 15

The surgical instrument of any one of Examples 7-14, wherein the secondsensor is disposed adjacent to a rotation point between the arm and theultrasonic blade such that the arm bears against the second sensor asthe arm transitions to the open position.

Example 16

A surgical instrument comprising: an ultrasonic blade, a transducerassembly coupled to the ultrasonic blade, a sensor configured to sense aforce thereagainst, and a control circuit coupled to the transducerassembly and the sensor. The transducer assembly comprises at least twopiezoelectric elements configured to ultrasonically oscillate theultrasonic blade. The control circuit is configured to activate thetransducer assembly according to the force sensed by the sensor relativeto a threshold force.

Example 17

The surgical instrument of Example 16, wherein the sensor comprises aforce sensitive resistor.

Example 18

The surgical instrument of Example 16 or 17, wherein the control circuitis configured to activate the transducer assembly when the force sensedby the sensor exceeds the threshold force.

Example 19

The surgical instrument of any one of Examples 16-18, wherein the sensoris disposed on an exterior surface of the surgical instrument.

Example 20

The surgical instrument of any one of Examples 16-19, wherein an outputof the sensor varies according to a degree of force thereagainst and thecontrol circuit is configured to activate the transducer assemblyaccording to the output of the sensor relative to a thresholdrepresentative of the threshold force.

1. A surgical instrument comprising: an ultrasonic blade; an armpivotable relative to the ultrasonic blade between an open position anda closed position; a transducer assembly coupled to the ultrasonicblade, the transducer assembly comprising at least two piezoelectricelements configured to ultrasonically oscillate the ultrasonic blade; asensor configured to sense a position of the arm between the openposition and the closed position; and a control circuit coupled to thetransducer assembly and the sensor, the control circuit configured toactivate the transducer assembly according to a position of the armdetected by the sensor relative to a threshold position.
 2. The surgicalinstrument of claim 1, wherein the sensor comprises a Hall effectsensor.
 3. The surgical instrument of claim 2, wherein the arm comprisesa magnet detectable by the Hall effect sensor.
 4. The surgicalinstrument of claim 2, wherein the Hall effect sensor is configured todetect a magnet disposed on a user.
 5. The surgical instrument of claim1, wherein the threshold position corresponds to the open position. 6.The surgical instrument of claim 1, wherein the threshold positioncorresponds to the closed position.
 7. A surgical instrument comprising:an ultrasonic blade; an arm pivotable relative to the ultrasonic bladebetween an open position and a closed position; a transducer assemblycoupled to the ultrasonic blade, the transducer assembly comprising atleast two piezoelectric elements configured to ultrasonically oscillatethe ultrasonic blade; a first sensor configured to sense a first forceas the arm transitions to the closed position; a second sensorconfigured to sense a second force as the arm transitions to the openposition; and a control circuit coupled to the transducer assembly, thefirst sensor, and the second sensor, the control circuit configured toactivate the transducer assembly according to the first force sensed bythe first sensor relative to a first threshold and the second forcesensed by the second sensor relative to a second threshold.
 8. Thesurgical instrument of claim 7, wherein the first sensor comprise atactile switch.
 9. The surgical instrument of claim 8, wherein thetactile switch comprises a two-stage tactile switch.
 10. The surgicalinstrument of claim 9, wherein the first threshold correspond to asecond stage of the two-stage tactile switch.
 11. The surgicalinstrument of claim 7, wherein the first sensor is disposed on a housingof the surgical instrument such that the arm bears thereagainst as thearm transitions to the closed position.
 12. The surgical instrument ofclaim 7, wherein the second sensor comprise a tactile switch.
 13. Thesurgical instrument of claim 12, wherein the tactile switch comprises aone-stage tactile switch.
 14. The surgical instrument of claim 7,wherein the second threshold correspond to a non-zero force.
 15. Thesurgical instrument of claim 7, wherein the second sensor is disposedadjacent to a rotation point between the arm and the ultrasonic bladesuch that the arm bears against the second sensor as the arm transitionsto the open position.
 16. A surgical instrument comprising: anultrasonic blade; a transducer assembly coupled to the ultrasonic blade,the transducer assembly comprising at least two piezoelectric elementsconfigured to ultrasonically oscillate the ultrasonic blade; a sensorconfigured to sense a force thereagainst; and a control circuit coupledto the transducer assembly and the sensor, the control circuitconfigured to activate the transducer assembly according to the forcesensed by the sensor relative to a threshold force.
 17. The surgicalinstrument of claim 16, wherein the sensor comprises a force sensitiveresistor.
 18. The surgical instrument of claim 16, wherein the controlcircuit is configured to activate the transducer assembly when the forcesensed by the sensor exceeds the threshold force.
 19. The surgicalinstrument of claim 16, wherein the sensor is disposed on an exteriorsurface of the surgical instrument.
 20. The surgical instrument of claim16, wherein: an output of the sensor varies according to a degree offorce thereagainst; and the control circuit is configured to activatethe transducer assembly according to the output of the sensor relativeto a threshold representative of the threshold force.